Use of biomaterials in scaphoid fracture fixation, a systematic review

Open AccessPublished:September 07, 2021DOI:https://doi.org/10.1016/j.clinbiomech.2021.105480

      Highlights

      • Use of bioabsorbable materials in scaphoid fixation is heterogeneous to date
      • Comparable union rates were found between bioabsorbable and conventional fixation
      • Larger studies are needed to evaluate outcomes in scaphoid fracture and non-union

      Abstract

      Background

      Scaphoid fractures account for 60–70% carpal injury. Due to limited vascular supply achieving adequate reduction and healing is important to avoid complications including avascular necrosis. Recent technological advances have led to renewed vigour in bioabsorbable material research to develop devices which could be used without the need for removal and complications including stress shielding and suboptimal imaging.

      Methods

      A systematic search of databases including PubMed, Ovid Medline, and Google Scholar databases was made to identify studies related to the use of bioabsorbable materials in scaphoid fixation and postoperative patient outcomes. PRISMA guidelines were utilised for this review.

      Findings

      Initial search results yielded 852 studies. 124 studies were screened, with 79 patients across 7 studies included in this review. Poly-L-Lactic acid derivatives were the most common biomaterial for scaphoid fixation, with magnesium and polyglycolide also used. Levels of evidence for studies ranged between III-IV. Analysis demonstrated mixed findings with generally comparable outcomes to conventional alloy-based screws.

      Interpretation

      Development in bioabsorbable materials is ongoing, however there remains a dearth in data regarding their use in the scaphoid. Further research is needed to establish the efficacy and applicability of bioabsorbable devices in the scaphoid bone.

      Keywords

      1. Introduction

      The scaphoid is the most commonly fractured carpal bone, accounting for 60–70% cases of carpal injuries (
      • Tysver T.
      • Jawa A.
      Fractures in brief: scaphoid fractures.
      ). Fractures occurring at the proximal pole are at increased risk of avascular necrosis and risk of non-union due to the poor vascular supply (
      • Tysver T.
      • Jawa A.
      Fractures in brief: scaphoid fractures.
      ). While good outcomes have been reported with cast immobilisation for minimally displaced scaphoids (
      • Buijze G.A.
      • Goslings J.C.
      • Rhemrev S.J.
      • et al.
      Cast immobilization with and without immobilization of the thumb for nondisplaced and minimally displaced scaphoid waist fractures: a multicenter, randomized, controlled trial.
      ), displaced fractures benefit from immediate surgical reduction (
      • Dias J.J.
      • Brealey S.D.
      • Fairhurst C.
      • et al.
      Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.
      ). Osteosynthesis devices most commonly used in scaphoid fixation include Kirschner wires, plates and screws (
      • Waris E.
      • Ashammakhi N.
      • Kaarela O.
      • Raatikainen T.
      • Vasenius J.
      Use of bioabsorbable osteofixation devices in the hand.
      ).
      Recent developments in technology and complications arising from conventionally used metallic screws in orthopaedic fracture fixation including stress shielding (
      • Haase K.
      • Rouhi G.
      Prediction of stress shielding around an orthopedic screw: using stress and strain energy density as mechanical stimuli.
      ), need for revision surgeries for removal of hardware (
      • Brown B.D.
      • Steinert J.N.
      • Stelzer J.W.
      • Yoon R.S.
      • Langford J.R.
      • Koval K.J.
      Increased risk for complications following removal of hardware in patients with liver disease, pilon or pelvic fractures: a regression analysis.
      ), suboptimal radiological imaging due to artifact (
      • Zhao B.
      • Qiu X.
      • Wang D.
      • Li H.
      • He X.
      Application of bioabsorbable screw fixation for anterior cervical decompression and bone grafting.
      ) has led to research into other potentially useful methods of fixation. Use of metallic screws is associated with increased economic burden from further procedures (
      • Partio N.
      • Huttunen T.T.
      • Maenpaa H.M.
      • Mattila V.M.
      Reduced incidence and economic cost of hardware removal after ankle fracture surgery: a 20-year nationwide registry study.
      ), with high corrosion rates and cytotoxicity resulting in late stage osteolysis also enumerated (
      • Staiger M.P.
      • Pietak A.M.
      • Huadmai J.
      • Dias G.
      Magnesium and its alloys as orthopedic biomaterials: a review.
      ). Finding material have the right combination of tensile and compressive strength, maximum elongation and a rate of corrosion are the primary challenges to quality fixation.
      The role of the scaphoid within the structure and the mechanics of the carpus, including steering and rotation of the longitudinal axis of the scaphoid is an important kinematic component to consider in scaphoid fracture repair. Bioabsorbable devices have recently been investigated with renewed vigour in bony fixation (
      • On S.W.
      • Cho S.W.
      • Byun S.H.
      • Yang B.E.
      Bioabsorbable osteofixation materials for maxillofacial bone surgery: a review on polymers and magnesium-based materials.
      ), with orthopaedic surgery having a long history of using absorbable metals intraoperatively with mixed results (
      • Pogorielov M.
      • Husak E.
      • Solodivnik A.
      • Zhdanov S.
      Magnesium-based biodegradable alloys: degradation, application, and alloying elements.
      ). However, the advantages of bioabsorbable material use in scaphoid fracture fixation have not been evaluated in the literature.

      2. Objective

      This review aims to systematically review the literature published on the use of bioabsorbable devices in management of patients with scaphoid fractures to evaluate efficacy of biodegradable devices in acute and chronic settings; additional use of bone grafting during repair; outcomes measured including rate of union achieved using this device method; functional outcomes measured, and associated complications occurring within the follow up outlined in each study.

      3. Methods

      3.1 Search strategy

      A systematic search was carried out according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA (
      • Moher D.
      • Liberati A.
      • Tetzlaff J.
      • Altman D.G.
      • Group P
      Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
      )) guidelines. Keyword combinations were applied including “*biodegrad” OR “*Bioabsorb” OR “magnesium” AND “scaphoid”, or any synonyms of this including “os scaphoideum” OR “os naviculare” OR “ossa carpi” OR “wrist fracture” AND “fracture” OR “fixation” OR “union” across three electronic databases consisting of PubMed, OVID Medline, and Google Scholar. No publication year filter was applied to ensure adequate capture of data. Similarly, published studies, preprints and books were included to optimise data available. Studies with full papers were required to ensure adequate data extraction and use of sound methodological approaches was feasible. Study selection identification was carried out between January–August 2021.
      Titles and abstracts of retrieved articles were read, with inclusion and exclusion criteria applied by two independent reviewers (AF;IF) (Table 1.) and if the inclusivity of the study was uncertain the study was read in full. In cases of disagreement between reviewers a third (CNF) reviewer was used to reach a consensus. Reference lists of included articles were evaluated for any additional research suitable for assessment. Articles were placed in Endnote to eliminate any duplicates. Inclusion and exclusion criteria below were applied to studies evaluated. Fig. 1 summarises the search carried out and the selection process following application of criteria enumerated below. Data extraction was carried out from included studies. Data pertaining to the use of bioabsorbable fixation in scaphoid fixation including study methodology; pathology; Herbert type; fixation method and comparator group if any; use of bone graft, and reported outcomes was collected. Ad-hoc tables were designed to summarise data from the included studies (Table 2). Descriptive statistics were expressed as mean ± SD. Inferential statistics were calculated using the IBM SPSS software (IBM Inc.). A difference was considered statistically significant if p < 0.05.
      Table 1Inclusion/exclusion criteria.
      Inclusion CriteriaExclusion Criteria
      Scaphoid fracture fixationNon-English Language Study
      Use of Bioabsorbable materialInclusion of other Carpal bones
      English language or adequately translated studiesAbstracts only
      Full article availablePoster presentations
      In vitro studies
      Table 2Articles included for review.
      AuthorMethodologyPathologyHerbert TypeFixation MethodComparisonBone GraftOutcomeLevel of Evidence
      Kujala et al. (2004) (
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      )
      N:6

      M6/F0

      Mean age:26



      Case series
      3x Scaphoid fracture

      3× non-union
      3×B2

      3×D2
      Self-reinforced poly-l-lactic acid (PLLA) screwsNoneIliac CrestUnion in 83.3%IV
      Ya'ish et al. (2013) (
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      )
      N:29

      M24/F5

      Mean age:27.8



      Prospective interventional study
      7× Unstable fracture 22× non-union5xB2

      1xB3

      1xB4

      6xD1

      13xD2
      PLLA and hydroxyapatite composite screwsNoneDistal Radius:13



      Distal Radius/Iliac Crest: 3
      Union in 72.4%III
      Akmaz et al. (2004) (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      )
      N:12

      M12/F0

      Mean age:22



      Prospective Interventional study
      Scaphoid Non-union10xD2 Middle 1/3 fracture line

      1xD2 Prox 1/3

      1xD1 distal 1/3 Fibrous union
      SR-PLLA pins and screwsNoneDistal Radius:12Union in 100% patientsIV
      Pelto-Vasenius (1995)

      18
      N:14/10

      M21/F3

      Mean age:24/25



      Case Control
      4xDelayed union

      19xNonunion
      Not describedPolyglycolide pinsHerbert ScrewsAnterior Iliac crest in all PGA and 6 of Herbert group64% Union in bio groupIII
      Wichelhaus et al. (2016) (
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      )
      N:1

      M42



      Case Study
      1 Scaphoid delayed unionB2Magnesium-based screws “Magnezix”NoneIliac CrestSevere SynovitisIV
      Yamamuro et al. (1994) (
      • Yamamuro T.
      • Matsusue Y.
      • Uchida A.
      • Shimada K.
      • Shimozaki E.
      • Kitaoka K.
      Bioabsorbable osteosynthetic implants of ultra high strength poly-L-lactide. A clinical study.
      )
      N:6

      Not enumerated



      Prospective Interventional study
      Scaphoid delayed union

      Scaphoid pseudoarthrosis
      Not specifiedPoly-L-lactic acid (PLLA) pinsNoneIliac crest1 case tendovaginitisIII
      Ek and Wang (2017) (
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      )
      N:1

      M45



      Case Study
      Proximal pole non-unionNot specifiedPLLA copolymer nail “SmartNail”NoneDistal RadiusUnionIV
      Study quality was assessed using the Risk of Bias Tools as per Cochrane guidelines, including assessment of bias occurring due to confounding factors, selection of participants, classifications of interventions applied, deviations from intended interventions, the presence of any missing data, any outcomes measured and reported results (
      • Sterne J.A.
      • Hernán M.A.
      • Reeves B.C.
      • et al.
      ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions.
      ). Studies demonstrating a serious risk of bias would be deemed to be low quality and were not included in the review.

      4. Results

      Following application of inclusion and exclusion criteria, 79 patients across seven studies were included for review (Fig. 1).
      Of the patient population included for analysis, 69 underwent fixation using bioabsorbable fixation devices, with ten receiving non-bioabsorbable methods of fixation in a comparator group. (Table 2.)
      Baseline demographics were available in six of the studies included, with homogeneity demonstrated. The mean age of included patients was 31 (SD±9.7), with males representing 89% of the study population. This is representative of the mean patient population presenting with scaphoid fractures and undergoing subsequent fixation (
      • Van Tassel D.C.
      • Owens B.D.
      • Wolf J.M.
      Incidence estimates and demographics of scaphoid fracture in the U.S. population.
      ).

      4.1 Study methodology

      Two case studies were included in this review (
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ;
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ). Wichelhaus et al (
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ) described two magnesium-based screws inserted as secondary fixation, with Ek and Wang (
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ) using a polylactic acid (PLA) co-polymer for fixation. Kujala et al. (
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ) used a case series consisting of six patients, with poly-l-lactic acid (PLLA) used in all patients.
      Three studies used a prospective interventional approach with a PLLA derivative for fixation. Akmaz et al. (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ) used a combination of pin and screw fixation with self-reinforced polylactide (SR-PLLA), with Ya'ish et al (
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      ) using fixation with combination PLLA and Hydroxyapatite. Yamamuro et al. (
      • Yamamuro T.
      • Matsusue Y.
      • Uchida A.
      • Shimada K.
      • Shimozaki E.
      • Kitaoka K.
      Bioabsorbable osteosynthetic implants of ultra high strength poly-L-lactide. A clinical study.
      ) used PLLA screw fixation.
      Pelto-Vasenius et al. (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) was the sole study to use a case-control approach to evaluate outcomes of polyglycolide (PGA) pins compared to conventional Herbert screw fixation.

      4.2 Length of time from injury to surgery

      Significant heterogeneity in time to surgery both between studies and participants within studies was noted. Ya'ish et al. (
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      ) had the widest range of mean length of time of injury in patients who achieved full union and those that did not, differing with 32.2 weeks and 134.1 weeks respectively (P = 0.28). Pelto-Vasenius (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) had a lag time of 62 months in the bioabsorbable pin group and 13 months in the group of patients with Herbert screws inserted. Kujala et al. (
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ) reported the average patient surgery occurred at 16 months post injury. Akmaz et al. (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ) reported a time to surgery of 9.8 months for included patients. Ek and Wang (
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ) reported on a patient who presented 3 months following his initial injury.
      Two studies did not outline the total follow up for included patients (
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ;
      • Yamamuro T.
      • Matsusue Y.
      • Uchida A.
      • Shimada K.
      • Shimozaki E.
      • Kitaoka K.
      Bioabsorbable osteosynthetic implants of ultra high strength poly-L-lactide. A clinical study.
      ) .

      4.3 Bone grafting

      Grafting of bone was included in all studies with a degree of heterogeneity. Bone grafting was used in four of the six scaphoid repairs in Kujala et al. (
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ), and sixteen of the twenty-nine cases in Ya'ish et al. (
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      ) Pelto-Vasenius et al. (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) used bone grafting in all cases with bioabsorbable fixation, and in all but two patients with traditional Herbert screw fixation, where the bone was deemed of sufficient quality to forego grafting. Three studies included in this review used bone grafting in their protocol (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ;
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ;
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ).

      4.4 Rates of union

      Ya'ish et al (
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      ) reported higher union rate in the fracture cohort compared to scaphoids with non-union (85.7% vs. 68.1%).
      Akmaz et al. (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ) had union in all patients postoperatively. Kujala et al. (
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ) noted union in 83.3% patients at the last follow-up time noted. Pelto-Vasenius et al. (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) in contrast noted union in 64% and 60% union in their bioabsorbable and Herbert screw fixation groups respectively.
      Of the two case studies; Wichelhaus et al (
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ) one removed the screw prior to union, with Ek and Wang (
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ) reporting successful scaphoid union.

      4.5 Functional outcome

      Functional outcomes postoperatively were reported with a degree of heterogeneity between studies. Four studies (
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ;
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ;
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ;
      • Yamamuro T.
      • Matsusue Y.
      • Uchida A.
      • Shimada K.
      • Shimozaki E.
      • Kitaoka K.
      Bioabsorbable osteosynthetic implants of ultra high strength poly-L-lactide. A clinical study.
      ) did not use a scoring tool to assess outcomes. Both Akmaz et al. (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ) and Kujala et al. (
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ) reported grading metrics for patients postoperative status with incomplete information on scoring parameters provided. Ya'ish et al. (
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      ) noted using a Jamar Dynamometer for assessment of grip strength within the Mayo wrist score calculated. They also graded outcomes based on total score using the Mayo Modified Green O'Brien Wrist score- excellent (81–100), good (66–80), moderate (51–65) or poor (0–50) outcomes.

      4.6 Follow up

      Yamamuro et al. (
      • Yamamuro T.
      • Matsusue Y.
      • Uchida A.
      • Shimada K.
      • Shimozaki E.
      • Kitaoka K.
      Bioabsorbable osteosynthetic implants of ultra high strength poly-L-lactide. A clinical study.
      ) had the longest follow up time for patients with a follow up of 3–5 years. Akmaz et al. (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ) reported a mean follow up of 25 months, while two studies carried out assessment at final follow a year postoperatively (
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ;
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      ). Pelto-Vasenius (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) described two follow up times for bioabsorbable and Herbert groups, seen at 68 weeks and 58 weeks respectively.
      Of the two case studies included in this review, Ek and Wang (
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ) followed up for a period of 6 months, with Wichelaus et al. (
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ) revising the operation at 6 weeks.

      4.7 Complications

      In the combined patient population of 69 patients reported in these 7 series with bioabsorbable fixation methods, 16 had complications consisting of eight discharging wounds, two cases of Sudek's Atrophy, two patients with removal of broken hardware required, and one patient each with infection, tenovaginitis, arthrosis and carpal tunnel syndrome. Of these, only Wichelhaus et al. (
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ) reported a poor outcome as a result of patient complications, with severe synovitis seen on removal. Ten patients in this review underwent Herbert screw fixation by Pelto-Vasenius (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ), with two of these requiring removal of metal due to impingement of radial cartilage.

      5. Discussion

      Choice of biomechanical material used for fixation purposes has been noted to affect the outcomes of bony repairs (
      • Hermawan H.
      Updates on the research and development of absorbable metals for biomedical applications.
      ). Common classes of biomechanical materials include ceramic, polymer, and metallic materials, with previously published data covering the myriad of absorbable materials and their relative advantages (
      • Hermawan H.
      Updates on the research and development of absorbable metals for biomedical applications.
      ;
      • Murni N.S.
      • Dambatta M.S.
      • Yeap S.K.
      • Froemming G.R.A.
      • Hermawan H.
      Cytotoxicity evaluation of biodegradable Zn-3Mg alloy toward normal human osteoblast cells.
      ). First generation biodegradable implants yielded mixed outcomes, with a high complication rate noted due to early reactions (
      • Böstman O.
      • Hirvensalo E.
      • Mäkinen J.
      • Rokkanen P.
      Foreign-body reactions to fracture fixation implants of biodegradable synthetic polymers.
      ). More recent generations have been purported to have slower degradation rates and lower tissue reaction rates, including (PLLA) (
      • Givissis P.K.
      • Stavridis S.I.
      • Papagelopoulos P.J.
      • Antonarakos P.D.
      • Christodoulou A.G.
      Delayed foreign-body reaction to absorbable implants in metacarpal fracture treatment.
      ). Efficacy of PLLA has been demonstrated across multiple joints in orthopaedic surgery (
      • Su Y.
      • Luo C.
      • Zhang Z.
      • et al.
      Bioinspired surface functionalization of metallic biomaterials.
      ;
      • Tsumiyama S.
      • Umeda G.
      • Ninomiya K.
      • Miyawaki T.
      Use of Unsintered hydroxyapatite and poly-L-lactic acid composite sheets for Management of Orbital Wall Fracture.
      ). Waris et al. (
      • Waris E.
      • Ashammakhi N.
      • Kaarela O.
      • Raatikainen T.
      • Vasenius J.
      Use of bioabsorbable osteofixation devices in the hand.
      ) noted the potential advantages of bioabsorbable fixation in the scaphoid. Four of the studies included in this review used a derivative of PLLA as the main compound in their device (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ;
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ;
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ;
      • Yamamuro T.
      • Matsusue Y.
      • Uchida A.
      • Shimada K.
      • Shimozaki E.
      • Kitaoka K.
      Bioabsorbable osteosynthetic implants of ultra high strength poly-L-lactide. A clinical study.
      ). Good outcomes were reported for patients across these studies, however three studies (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ;
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ;
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ) did not identify criteria by which they graded patient outcomes, limiting generalisability of the findings. Yamamuro et al. (
      • Yamamuro T.
      • Matsusue Y.
      • Uchida A.
      • Shimada K.
      • Shimozaki E.
      • Kitaoka K.
      Bioabsorbable osteosynthetic implants of ultra high strength poly-L-lactide. A clinical study.
      ) noted that although patients had good outcome with the polylactic acid (PLLA) device used in their study, authors felt suitability of the compound should remain restricted from high load joints, long bones and the pelvis. Current applications of PLLA within Orthopaedic surgery is varied, commonly used in primarily small joint and soft tissue fixation (
      • Narayanan G.
      • Vernekar V.N.
      • Kuyinu E.L.
      • Laurencin C.T.
      Poly (lactic acid)-based biomaterials for orthopaedic regenerative engineering.
      ).
      PLLA-based composite fixation devices have been investigated with increasing regularity in the literature (
      • Bakhsheshi-Rad H.R.
      • Ismail A.F.
      • Aziz M.
      • et al.
      Co-incorporation of graphene oxide/silver nanoparticle into poly-L-lactic acid fibrous: a route toward the development of cytocompatible and antibacterial coating layer on magnesium implants.
      ). Limitations of PLLA including lack of biocompatibility has encouraged researchers to identify material composites to increase PLLA biocompatibility and biointegration (
      • Kang I.G.
      • Kim J.
      • Park S.
      • Kim H.E.
      • Han C.M.
      PLLA membrane with embedded hydroxyapatite patterns for improved bioactivity and efficient delivery of growth factor.
      ). Lee et al. (
      • Lee D.W.
      • Lee J.W.
      • Kim S.B.
      • et al.
      Comparison of poly-L-lactic acid and poly-L-lactic acid/hydroxyapatite bioabsorbable screws for Tibial fixation in ACL reconstruction: clinical and magnetic resonance imaging results.
      ) found PLLA/Hydroxyapatite composite screws resulted in reduced foreign body reactions compared to PLLA alone when used in tibial fixation during ACL reconstruction. Improved osteointegration was also noted. Further efforts to mitigate potential implant failure as a result of bone infection following biomaterial bone implantation have also been evaluated. Liu et al. (
      • Liu F.
      • Wang X.
      • Chen T.
      • et al.
      Hydroxyapatite/silver electrospun fibers for anti-infection and osteoinduction.
      ) noted the addition of silver-based coating compounds further reduces the risk of implant infection, with osteoinductivity noted to increase with this compound. Only Ya'ish et al. (
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      ) in this review used a composite biocompound for scaphoid fixation. While no postoperative infection was noted, two patients presented with non-union following fragmentation of screws, requiring further procedures with additional grafting required to achieve fixation.
      At present, use of magnesium as a bio-compound demonstrates the greatest evidence of clinical efficacy in the literature; with non-inferiority demonstrated in small and large joint procedures (
      • Lee J.W.
      • Han H.S.
      • Han K.J.
      • et al.
      Long-term clinical study and multiscale analysis of in vivo biodegradation mechanism of mg alloy.
      ;
      • Plaass C.
      • von Falck C.
      • Ettinger S.
      • et al.
      Bioabsorbable magnesium versus standard titanium compression screws for fixation of distal metatarsal osteotomies - 3 year results of a randomized clinical trial.
      ). Large scale trials have been recommended to further evaluate the benefits and potential complications of this bio compound (
      • Zhao D.
      • Witte F.
      • Lu F.
      • Wang J.
      • Li J.
      • Qin L.
      Current status on clinical applications of magnesium-based orthopaedic implants: a review from clinical translational perspective.
      ) with findings from a non-inferiority trial comparing Magnesium based Herbert screw outcomes to conventional titanium-based Herbert screws used in scaphoid fractures (
      • Könneker S.
      • Krockenberger K.
      • Pieh C.
      • et al.
      Comparison of SCAphoid fracture osteosynthesis by MAGnesium-based headless Herbert screws with titanium Herbert screws: protocol for the randomized controlled SCAMAG clinical trial.
      ) expected to provide recommendations on its use as a biomaterial based fixation method of the scaphoid. Only Wichelhaus et al (
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ) in this review used magnesium-based devices in their study design. Post-operative complications arising from insertion of the device necessitated removal of the device.
      Suitable biodegradable materials which will provide a non-inferior result to the classical titanium Herbert screws remain an ongoing source of research, including optimum coating materials (
      • Wang W.
      • Nune K.C.
      • Tan L.
      • et al.
      Bone regeneration of hollow tubular magnesium-strontium scaffolds in critical-size segmental defects: effect of surface coatings.
      ). Integration of coatings appear to have helped mitigate local reactions, with polydioxanone (PDS) coatings noted to have a higher rate of reactions occurring than devices without coating (
      • Böstman O.
      • Partio E.
      • Hirvensalo E.
      • Rokkanen P.
      Foreign-body reactions to polyglycolide screws. Observations in 24/216 malleolar fracture cases.
      ). Pelto-Vasenius et al. (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) used PDS coating in conjunction with PGA for fixation, which they felt contributed to the relatively high complication rate of the PGA group and the formation of sterile sinuses. However early use of polyglycolide (PGA) was also associated with the formation of sterile sinuses (
      • Böstman O.
      • Hirvensalo E.
      • Mäkinen J.
      • Rokkanen P.
      Foreign-body reactions to fracture fixation implants of biodegradable synthetic polymers.
      ). The use of PGA/PDS in orthopaedic fixation is no longer commonly used, and the findings of this study should be taken in the context of the technological advancement made in composition since the publication of this study.
      Late phase foreign body reactions have been reported following biomaterial use both in the early and late postoperative phase (
      • Doh G.
      • Bahk S.
      • Hong K.Y.
      • Lim S.
      • Han K.M.
      • Eo S.
      Delayed formation of sterile abscess after zygomaticomaxillary complex fracture treatment with bioabsorbable plates.
      ;
      • Weiss K.S.
      • Weatherall J.M.
      • Eick J.
      • Ross J.R.
      Delayed Tibial osteomyelitis after anterior cruciate ligament reconstruction with hamstrings autograft and bioabsorbable interference screw: a case report and review of the literature.
      ). Both Waris et al. (
      • Waris E.
      • Ashammakhi N.
      • Kaarela O.
      • Raatikainen T.
      • Vasenius J.
      Use of bioabsorbable osteofixation devices in the hand.
      ) and Givissis et al. (
      • Givissis P.K.
      • Stavridis S.I.
      • Papagelopoulos P.J.
      • Antonarakos P.D.
      • Christodoulou A.G.
      Delayed foreign-body reaction to absorbable implants in metacarpal fracture treatment.
      ) evaluated the use of third generation synthetic biodegradable screws in metacarpal fractures, finding postoperative tissue reactions presented in a delayed manner. Anatomic location appeared to influence the rate of local reactions, with the scaphoid particularly at risk (
      • Böstman O.M.
      • Pihlajamäki H.K.
      Adverse tissue reactions to bioabsorbable fixation devices.
      ), possibly as a result of the poor vascular supply to the bone (
      • Losken H.W.
      • van Aalst J.A.
      • Mooney M.P.
      • et al.
      Biodegradation of inion fast-absorbing biodegradable plates and screws.
      ). Both studies highlighted the need for longer follow up in patients undergoing bioabsorbable fixation. Heterogeneity both between studies and between patients within study cohorts was noted. While the mean follow up time for patients was between one to two years, ongoing reports of delayed complications 2–4 years following bioabsorbable fixation devices in the literature (
      • Dumlao P.I.E.
      • Paner N.
      • Bathan L.
      • Lim B.A.
      Delayed onset bioabsorbable screw reaction, intact screw extrusion and Pseudomonas aeruginosa tibial tunnel osteomyelitis years after arthroscopic anterior cruciate ligament reconstruction using hamstring graft.
      ) necessitates surgeons to remain vigilant for late phase reactions to occur in these patients.
      Patients with maintained radiographic non-union can have improved functional outcomes with reduced pain (
      • Janowski J.
      • Coady C.
      • Catalano 3rd., L.W.
      Scaphoid fractures: nonunion and Malunion.
      ). Factors contributing to union rates include type of graft used (
      • Janowski J.
      • Coady C.
      • Catalano 3rd., L.W.
      Scaphoid fractures: nonunion and Malunion.
      ;
      • Rahimnia A.
      • Rahimnia A.H.
      • Mobasher-Jannat A.
      Clinical and functional outcomes of vascularized bone graft in the treatment of scaphoid non-union.
      ) and the interval period between injury and surgical intervention (
      • Kawamura K.
      • Chung K.C.
      Treatment of scaphoid fractures and nonunions.
      ). Four studies in this review used Iliac crest graft (
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ;
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ;
      • Wichelhaus A.
      • Emmerich J.
      • Mittlmeier T.
      A case of implant failure in partial wrist fusion applying magnesium-based headless bone screws.
      ;
      • Yamamuro T.
      • Matsusue Y.
      • Uchida A.
      • Shimada K.
      • Shimozaki E.
      • Kitaoka K.
      Bioabsorbable osteosynthetic implants of ultra high strength poly-L-lactide. A clinical study.
      ), and two harvested distal radius bone for grafting (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ;
      • Ek E.T.
      • Wang K.
      Fixation of Ultrasmall Proximal Pole Scaphoid Fractures Using Bioabsorbable Osteochondral Fixation Nails.
      ). Ya'ish et al. (
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      ) us a combination of these two in 3 patients. Pelto-Vasenius et al. (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) was the sole study to forego grafting, in two patients in the Herbert group where the bone was deemed to be of sufficient quality. Union rates following distal radius and iliac crest grafting have yielded comparable outcomes (
      • Janowski J.
      • Coady C.
      • Catalano 3rd., L.W.
      Scaphoid fractures: nonunion and Malunion.
      ). Three studies included in this review found the functional outcomes in some patients had improved despite lack of radiological evidence of reduction. Ya'ish et al. (
      • Ya’ish F.
      • Bailey C.A.
      • Kelly C.P.
      • Craigen M.A.
      Bioabsorbable fixation of scaphoid fractures and non-unions; analysis of early clinical outcomes.
      ) reported a union rate of 68% for patients presenting with scaphoid non-unions. In contrast, Akmaz et al. (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ) achieved union in all cases included in their study, noting that as the use of biodegradable implants increases in orthopaedics the successful outcomes match that of previously established and acceptable rates of metallic implant successes. Pelto-Vasenius et al. (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) had a lower rate of unions achieved in the PGA group compared to both the Herbert Screw group and other studies included in this review. However, the mean duration from injury to surgery in the PGA was more than four times that of the Herbert screws, a bias which must be considered when comparing outcomes.
      Loss of stress shielding has been cited as a potential advantage of bioabsorbable screws, with gradual screw degradation resulting in incremental load conferred to the native bone (
      • Figueiredo L.
      • Fonseca R.
      • Pinto L.F.V.
      • Ferreira F.C.
      • Almeida A.
      • Rodrigues A.
      Strategy to improve the mechanical properties of bioabsorbable materials based on chitosan for orthopedic fixation applications.
      ;
      • Haase K.
      • Rouhi G.
      Prediction of stress shielding around an orthopedic screw: using stress and strain energy density as mechanical stimuli.
      ). Magnesium-based bioabsorbable fixation has demonstrated similar clinical outcomes to conventional titanium-based screw fixation (
      • Acar B.
      • Kose O.
      • Unal M.
      • Turan A.
      • Kati Y.A.
      • Guler F.
      Comparison of magnesium versus titanium screw fixation for biplane chevron medial malleolar osteotomy in the treatment of osteochondral lesions of the talus.
      ;
      • Kose O.
      • Turan A.
      • Unal M.
      • Acar B.
      • Guler F.
      Fixation of medial malleolar fractures with magnesium bioabsorbable headless compression screws: short-term clinical and radiological outcomes in eleven patients.
      ), with PLLA demonstrating similar results (
      • Saxena A.
      Bioabsorbable screws for reduction of Lisfranc's diastasis in athletes.
      ). To date these biomaterial-based alloys have demonstrated the greatest efficacy for yielding positive outcomes in scaphoid fracture fixation, optimising the reliability of conventional screw fixation with the benefits of bioabsorbable materials. At present, supplementary fixation appears to be a common method of reinforcement, as demonstrated by three studies (
      • Akmaz I.
      • Kiral A.
      • Pehlivan O.
      • Mahirogullari M.
      • Solakoglu C.
      • Rodop O.
      Biodegradable implants in the treatment of scaphoid nonunions.
      ;
      • Kujala S.
      • Raatikainen T.
      • Kaarela O.
      • Ashammakhi N.
      • Ryhänen J.
      Successful treatment of scaphoid fractures and nonunions using bioabsorbable screws: report of six cases.
      ;
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) in this review, which limited analysis of benefits derived from gradual incremental loading through use of bioabsorbable fixation devices. Although the addition of titanium reinforcement was used in some patients in the PGA group; Pelto-Vasenius et al. (
      • Pelto-Vasenius K.
      • Hirvensalo E.
      • Böstman O.
      • Rokkanen P.
      Fixation of scaphoid delayed union and non-union with absorbable polyglycolide pin or Herbert screw. Consolidation and functional results.
      ) noted the grip strength found in the PGA group was inferior, despite a higher reported union rate. The operated hand in the PGA group was found to have 87% strength of the unaffected hand, compared to 96% strength of the unaffected hand in the Herbert group.

      5.1 Limitations

      This review has several limitations. The published data from clinical studies are not homogenous, with a heterogenous use of biomaterial used in scaphoid fixation, in addition to the fixation method used. Several biomaterials (PLDLLA, PLLA and PGA) have been evaluated in a variety of conditions. The number of patients in each study series was relatively small. Despite this, the results of our findings highlight the dearth of current applications of bioabsorbable in scaphoid fixation, highlighting the potential benefits to be derived from biomaterial use in the scaphoid bone.

      6. Conclusion

      Scaphoid fractures are a common orthopaedic condition, with potentially severe complications including poor functional outcomes and osteoarthritis if inadequate reduction occurs. Osteosynthesis devices continue to pose potential difficulties including the need for removal. Biodegradable devices are promising alternatives to conventional alloys used. PLLA demonstrates comparable union rates to conventional methods of scaphoid fixation to date, however large trials are required to evaluate the use of recent technological advances in biomaterials in acute and chronic non-union fixation of the scaphoid.

      Sources of funding

      No financial support for the research, and collation of data was received by authors for this article.

      Ethical approval

      Ethical Approval was not required for this systematic review.

      Statement for human and animal rights

      This article does not contain any studies with human or animal subjects.

      Declaration of Competing Interest

      No potential conflicts of interest regarding the research, authorship, and/or publication of this article was noted by the authors.

      Acknowledgements

      None.

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