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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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          Abstract

          Background

          Scaphoid fractures are the most common carpal fractures. They often need to be treated by surgery, where the use of a compression screw is the globally accepted gold standard. Surgeons may choose between different implant materials including titanium alloys, which remain in the body or are removed after healing. An alternative are biodegradable magnesium-based implants. Properties of magnesium alloys include high stability, osteoconductivity, potential reduction of infections and few artifacts in magnetic resonance imaging (MRI). The aim of this trial is to demonstrate non-inferiority of magnesium-based compression screws compared with titanium Herbert screws for scaphoid fractures.

          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.

          Discussion

          This study will inform care providers whether biodegradable magnesium-based implants are non-inferior to standard 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.

          Trial registration

          DRKS, DRKS00013368. Registered Dec 04, 2017.

          Electronic supplementary material

          The online version of this article (10.1186/s12891-019-2723-9) contains supplementary material, which is available to authorized users.

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          Most cited references43

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          Interval estimation for the difference between independent proportions: comparison of eleven methods

          Several existing unconditional methods for setting confidence intervals for the difference between binomial proportions are evaluated. Computationally simpler methods are prone to a variety of aberrations and poor coverage properties. The closely interrelated methods of Mee and Miettinen and Nurminen perform well but require a computer program. Two new approaches which also avoid aberrations are developed and evaluated. A tail area profile likelihood based method produces the best coverage properties, but is difficult to calculate for large denominators. A method combining Wilson score intervals for the two proportions to be compared also performs well, and is readily implemented irrespective of sample size.
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            Degradable biomaterials based on magnesium corrosion

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              CONSORT for reporting randomised trials in journal and conference abstracts.

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                Author and article information

                Contributors
                +49 511 532 8865 , koenneker.soeren@mh-hannover.de
                k.krockenberger@amedon.de
                pieh@syntellix.com
                falck.christian.von@mh-hannover.de
                b.brandewiede@amedon.de
                vogt.peter@mh-hannover.de
                kirschner@syntellix.com
                +49 451 989 60 279 , ziegler@statsol.de
                Journal
                BMC Musculoskelet Disord
                BMC Musculoskelet Disord
                BMC Musculoskeletal Disorders
                BioMed Central (London )
                1471-2474
                7 August 2019
                7 August 2019
                2019
                : 20
                : 357
                Affiliations
                [1 ]ISNI 0000 0000 9529 9877, GRID grid.10423.34, Department of Plastic, Aesthetic, Hand and Reconstructive Surgery, , Hanover Medical School (MHH), ; Carl-Neuberg-Straße 1, 30625 Hannover, Germany
                [2 ]GRID grid.491636.f, Amedon GmbH, ; Willy-Brandt-Allee 31c, 23554 Lübeck, Germany
                [3 ]GRID grid.492248.1, Syntellix AG, ; Aegidientorplatz 2a, 30159 Hannover, Germany
                [4 ]ISNI 0000 0000 9529 9877, GRID grid.10423.34, Institute for Diagnostic and Interventional Radiology, , Hanover Medical School, ; Carl-Neuberg-Str. 1, 30625 Hannover, Germany
                [5 ]ISNI 0000 0004 1936 973X, GRID grid.5252.0, Department for General, Trauma and Reconstructive Surgery, , Ludwig-Maximilians University of Munich, ; Marchioninistraße 15, 81377 Munich, Germany
                [6 ]StatSol, Moenring 2, 23560 Lübeck, Germany
                [7 ]ISNI 0000 0001 0723 4123, GRID grid.16463.36, School of Mathematics, Statistics and Computer Science, , University of KwaZulu-Natal, ; Pietermaritzburg, South Africa
                Author information
                http://orcid.org/0000-0002-8386-5397
                Article
                2723
                10.1186/s12891-019-2723-9
                6685162
                31387574
                b48cd22c-a7df-477f-89df-7eaaf440b887
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 23 January 2019
                : 26 June 2019
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2019

                Orthopedics
                herbert screw,magnesium alloy,magnetic resonance imaging,non-inferiority,patient-rated wrist evaluation,quality of life,scaphoid fracture,titanium alloy

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