gms | German Medical Science

14th Triennial Congress of the International Federation of Societies for Surgery of the Hand (IFSSH), 11th Triennial Congress of the International Federation of Societies for Hand Therapy (IFSHT)

17.06. - 21.06.2019, Berlin

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Comparison of SCAphoid fracture osteosynthesis by MAGnesium-based headless Herbert screws with titanium Herbert screws: protocol for the randomized controlled SCAMAG clinical trial

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  • presenting/speaker Sören Könneker - Medizische Hochschule Hannover, PÄHW-Chirurgie, Hannover, Germany
  • Katja Krockenberger - Amedon GmbH, Lübeck, Germany
  • Bernd Brandewiede - Amedon GmbH, Lübeck, Germany
  • Claudia Pieh - Syntellix AG, Hannover, Germany
  • Christian Con Falck - Medizinische Hochschule Hannover, Institut für Diagnostische und Interventionelle Radiologie, Hannover, Germany
  • Peter M. Vogt - Medizische Hochschule Hannover, PÄHW-Chirurgie, Hannover, Germany
  • Martin Kirschner - Syntellix AG, Hannover, Germany
  • Andreas Ziegler - StatSol, Lübeck, Germany

International Federation of Societies for Surgery of the Hand. International Federation of Societies for Hand Therapy. 14th Triennial Congress of the International Federation of Societies for Surgery of the Hand (IFSSH), 11th Triennial Congress of the International Federation of Societies for Hand Therapy (IFSHT), 11th Triennial Congress of the International Federation of Societies for Hand Therapy (IFSHT). Berlin, 17.-21.06.2019. Düsseldorf: German Medical Science GMS Publishing House; 2020. DocIFSSH19-730

doi: 10.3205/19ifssh1201, urn:nbn:de:0183-19ifssh12013

Published: February 6, 2020

© 2020 Könneker et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

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Objectives/Interrogation: Comparison of SCAphoid fracture osteosynthesis by MAGnesium-based headless Herbert screws with titanium Herbert screws: protocol for the randomized controlled SCAMAG clinical trial

Methods: The trial is designed as a multicenter, blinded observer, randomized controlled parallel two-group post market trial. Approximately 190 patients will be randomized (1:1) with stratification by center either to titanium or magnesium-based compression screws. Follow-up is 1 year per patient. Surgical procedures and aftercare will be performed according to the German treatment guideline for scaphoid fractures. The first primary endpoint is the patient-rated wrist evaluation (PRWE) score after 6 months. The second primary endpoint is a composite safety endpoint including bone union until 6 months, no adverse device effect (ADE) during surgery or wound healing and no serious ADE or reoperation within 1 year. The third primary endpoint is the difference in change MRI artifacts over time. Non-inferiority will be investigated for primary endpoints 1 (t-test confidence interval) and 2 (Wilson's score interval) using both the full analysis set (FAS) and the per protocol population at the one-sided 2.5% test-level. Superiority of magnesium over titanium screws will be established using the FAS at the two-sided 5% test-level (Welch test) only if non-inferiority has been established for both primary endpoints. Secondary endpoints include quality of life.

Results and Conclusions: This study will inform care providers whether biodegradable magnesium-based implants are non-inferior to classical titanium Herbert screws for the treatment of scaphoid fractures in terms of wrist function and safety. Furthermore, superiority of magnesium-based implants may be demonstrated using MRI, which is used as surrogate endpoint for screw degradation.