Advertisement
Original Article| Volume 23, ISSUE 2, P321-327, March 2018

Bioabsorbable magnesium versus standard titanium compression screws for fixation of distal metatarsal osteotomies – 3 year results of a randomized clinical trial

Published:November 23, 2017DOI:https://doi.org/10.1016/j.jos.2017.11.005

      Abstract

      Background

      For the treatment of hallux valgus commonly distal metatarsal osteotomies are performed. Persistent problems due to the hardware and the necessity of hardware removal has led to the development of absorbable implants. To overcome the limitations of formerly used materials for biodegradable implants, recently magnesium has been introduced as a novel implant material. This is the first study showing mid-term clinical and radiological (MRI) data after using magnesium implants for fixation of distal metatarsal osteotomies.

      Material and methods

      26 patients with symptomatic hallux valgus were included in the study. They were randomly selected to be treated with a magnesium or standard titanium screw for fixation of a modified distal metatarsal osteotomy. The patients had a standardized clinical follow up and MRI investigation 3 years' post-surgery. The clinical tests included the range of motion of the MTP 1, the AOFAS, FAAM and SF-36 scores. Further on the pain was evaluated on a VAS.

      Results

      Eight patients of the magnesium group and 6 of the titanium group had a full clinical and MRI follow up 3 years postoperatively. One patient was lost to follow-up. All other patients could be interviewed, but denied full study participation. There was a significant improvement for all tested clinical scores (AOFAS, SF-36, FAAM, Pain-NRS) from pre-to postoperative investigation, but no statistically relevant difference between the groups. Magnesium implants showed significantly less artifacts in the MRI, no implant related cysts were found and the implant was under degradation three years postoperatively.

      Conclusion

      In this study, bioabsorbable magnesium implants showed comparable clinical results to titanium standard implants 3 years after distal modified metatarsal osteotomy and were more suitable for radiologic analysis.

      Level of evidence

      2.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Orthopaedic Science
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Bargman J.
        • Corless J.
        • Gross A.E.
        • Lange F.
        A review of surgical procedures for hallux valgus.
        Foot Ankle. 1980 Jul; 1: 39-43
        • Ahn J.Y.
        • Lee H.S.
        • Chun H.
        • Kim J.S.
        • Seo D.K.
        • Choi Y.R.
        • Kim S.W.
        Comparison of open lateral release and transarticular lateral release in distal chevron metatarsal osteotomy for hallux valgus correction.
        Int Orthop. 2013 Sep; 37: 1781-1787
        • Park Y.-B.
        • Lee K.-B.
        • Kim S.-K.
        • Seon J.-K.
        • Lee J.-Y.
        Comparison of distal soft-tissue procedures combined with a distal chevron osteotomy for moderate to severe hallux valgus: first web-space versus transarticular approach.
        J Bone Jt Surg Am. 2013 Nov; 6; 95: e158
        • Katou F.
        • Andoh N.
        • Motegi K.
        • Nagura H.
        Immuno-inflammatory responses in the tissue adjacent to titanium miniplates used in the treatment of mandibular fractures.
        J Craniomaxillofac Surg. 1996 Jun; 24: 155-162
        • Hanft J.R.
        • Kashuk K.B.
        • Bonner A.C.
        • Toney M.
        • Schabler J.
        Rigid internal fixation of the Austin/Chevron osteotomy with Herbert screw fixation: a retrospective study.
        J Foot Surg. 1992 Sep-Oct; 31: 512-518
        • Ernstberger T.
        • Buchhorn G.
        • Heidrich G.
        Artifacts in spine magnetic resonance imaging due to different intervertebral test spacers: an in vitro evaluation of magnesium versus titanium and carbon-fiber-reinforced polymers as biomaterials.
        Neuroradiology. 2009 Aug; 51: 525-529
        • Stradiotti P.
        • Curti A.
        • Castellazzi G.
        • Zerbi A.
        Metal-related artifacts in instrumented spine. Techniques for reducing artifacts in CT and MRI: state of the art.
        Eur Spine J. 2009 Jun; 18: 102-108
        • Hirvensalo E.
        • Böstman O.
        • Törmälä P.
        • Vainionpää S.
        • Rokkanen P.
        Chevron osteotomy fixed with absorbable polyglycolide pins.
        Foot Ankle. 1991 Feb; 11: 212-218
        • Caminear D.S.
        • Pavlovich R.
        • Pietrzak W.S.
        Fixation of the chevron osteotomy with an absorbable copolymer pin for treatment of hallux valgus deformity.
        J Foot Ankle Surg. 2005 May-Jun; 44: 203-210
        • Pavlovich R.
        • Caminear D.
        Granuloma formation after chevron osteotomy fixation with absorbable copolymer pin: a case report.
        J Foot Ankle Surg. 2003 Jul-Aug; 42: 226-229
        • Böstman O.M.
        • Pihlajamäki H.K.
        Adverse tissue reactions to bioabsorbable fixation devices.
        Clin Orthop Relat Res. 2000 Feb; 371: 216-227
        • Seitz J.M.
        • Durisin M.
        • Goldman J.
        • Drelich J.W.
        Recent advances in biodegradable metals for medical sutures: a critical review.
        Adv Healthc Mater. 2015 Sep 16; 4: 1915-1936
        • Seitz J.-M.
        • Eifler R.
        • Bach F.-W.
        • Maier H.J.
        Magnesium degradation products: effects on tissue and human metabolism.
        J Biomed Mater Res A. 2014 Oct; 102: 3744-3753
        • Castellani C.
        • Lindtner R.A.
        • Hausbrandt P.
        • Tschegg E.
        • Stanzl-Tschegg S.E.
        • Zanoni G.
        • Beck S.
        • Weinberg A.M.
        Bone-implant interface strength and osseointegration: biodegradable magnesium alloy versus standard titanium control.
        Acta Biomater. 2011 Jan; 7: 432-440
        • Li R.W.
        • Kirkland N.T.
        • Truong J.
        • Wang J.
        • Smith P.N.
        • Birbilis N.
        • Nisbet D.R.
        The influence of biodegradable magnesium alloys on the osteogenic differentiation of human mesenchymal stem cells.
        J Biomed Mater Res A. 2014 Dec; 102: 4346-4357
        • Witte F.
        • Kaese V.
        • Haferkamp H.
        • Switzer E.
        • Meyer-Lindenberg A.
        • Wirth C.J.
        In vivo corrosion of four magnesium alloys and the associated bone response.
        Biomaterials. 2005 Jun; 26: 3557-3563
        • Ezechieli M.
        • Diekmann J.
        • Weizbauer A.
        • Becher C.
        • Willbold E.
        • Helmecke P.
        • Lucas A.
        • Schavan R.
        • Windhagen H.
        Biodegradation of a magnesium alloy implant in the intercondylar femoral notch showed an appropriate response to the synovial membrane in a rabbit model in vivo.
        J Biomater Appl. 2014 Aug; 29: 291-302
        • Windhagen H.
        • Radtke K.
        • Weizbauer A.
        • Diekmann J.
        • Noll Y.
        • Kreimeyer U.
        • Schavan R.
        • Stukenborg-Colsman C.
        • Waizy H.
        Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study.
        Biomed Eng Online. 2013 Jul 3; 12: 62
        • Altmann D.G.
        Practical statistics for medical research. Boca ration.
        Chapman & Hall, 1990
        • Trnka H.J.
        • Zembsch A.
        • Easley M.E.
        • Salzer M.
        • Ritschl P.
        • Myerson M.S.
        The chevron osteotomy for correction of hallux valgus. Comparison of findings after two and five years of follow-up.
        J Bone Jt Surg Am. 2000 Oct; 82-A: 1373-1378
        • Minkowitz R.B.
        • Bhadsavle S.
        • Walsh M.
        • Egol K.A.
        Removal of painful orthopaedic implants after fracture union.
        J Bone Jt Surg Am. 2007 Sep; 89: 1906-1912
        • Austin D.W.
        • Leventen E.O.
        A new osteotomy for hallux valgus: a horizontally directed “V” displacement osteotomy of the metatarsal head for hallux valgus and primus varus.
        Clin Orthop Relat Res. 1981 Jun; 157: 25-30
        • Smith S.E.
        • Landorf K.B.
        • Butterworth P.A.
        • Menz H.B.
        Scarf versus chevron osteotomy for the correction of 1–2 intermetatarsal angle in hallux valgus: a systematic review and meta-analysis.
        J Foot Ankle Surg. 2012 Jul–Aug; 51: 437-444
        • Pihlajamäki H.
        • Böstman O.
        • Tynninen O.
        • Laitinen O.
        Long-term tissue response to bioabsorbable poly-l-lactide and metallic screws: an experimental study.
        Bone. 2006 Oct; 39: 932-937
        • Weiler A.
        • Hoffmann R.F.
        • Stähelin A.C.
        • Helling H.J.
        • Südkamp N.P.
        Biodegradable implants in sports medicine: the biological base.
        Arthroscopy. 2000 Apr; 16: 305-321
        • Dujardin J.
        • Vandenneucker H.
        • Bellemans J.
        Tibial cyst and intra-articular granuloma formation after anterior cruciate ligament reconstruction using polylactide carbonate osteoconductive interference screws.
        Arthroscopy. 2008 Feb; 24: 238-242
        • Thompson S.M.
        • Fung S.
        • Wood D.G.
        The natural history of biointerference screw cyst and new bone formation in anterior cruciate ligament reconstruction: 16-year follow-up.
        Am J Sports Med. 2016 Jan; 44: 113-117
        • Diekmann J.
        • Bauer S.
        • Weizbauer A.
        • Willbold E.
        • Windhagen H.
        • Helmecke P.
        • Lucas A.
        • Reifenrath J.
        • Nolte I.
        • Ezechieli M.
        Examination of a biodegradable magnesium screw for the reconstruction of the anterior cruciate ligament: a pilot in vivo study in rabbits.
        Mater Sci Amp Eng C. 2016 Feb; 59: 1100-1109
        • Seitz J.-M.
        • Lucas A.
        • Kirschner M.
        Magnesium-based compression screws: a novelty in the clinical use of implants.
        JOM. 2016; 68: 1177-1182