Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System

Обзор

This is a randomized controlled trial comparing the DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) with the standard DELTA Xtend Reverse Shoulder System (control group). All Danish citizens with rotator cuff arthropathy or degeneration of the glenohumeral joint with severe posterior wear indicating a reverse total shoulder arthroplasty referred to the orthopedic department at Herlev and Gentofte Hospital, Copenhagen University Hospital will be considered for participation in the trial. The following exclude from participation in the study: Below 50 years of age; Cognitive or linguistic impairment; insufficient glenoid bone stock; previous fracture in the upper extremities; autoimmune mediated inflammatory arthritis.A total of 122 patients will be included of which 56 will be part of the roentgen radiostereometric analysis. This will allow a maximum of 20% drop out. The primary outcome is magnitude and pattern of migration of the glenoid component and functional outcome by Western Ontario Osteoarthritis of the Shoulder Index (WOOS score). The secondary outcomes are position of arthroplasty, loosening, inferior scapular notching, patient-reported outcomes, functional outcome, readmission, complications, revisions, changes in bone mineral density of the proximal humerus assessed by duel energy x-ray absorptiometry and economy (cost utility analysis). The patients are examined before the operation and 1 week and 3, 6, 12 and 24 months after the operation.

Вмешательства

• Процедура Reverse shoulder arthroplsaty
  Patients with the diagnosis of rotator cuff arthropathy (degeneration of the glenohumeral joint and wear or tear of at least one rotator cuff tendon) or degeneration of the glenohumeral joint with severe posterior wear with an indication of a reverse total shoulder arthroplasty

Первичные конечные точки

• Radiostereometric analysis (RSA) [ Time Frame: Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively ] [Срок оценки: At 1 week and at 3 months, 6 months, 1 year and 2 years]
• Western Ontario Osteoarthritis of the Shoulder index (WOOS) [ Time Frame: Change in WOOS score from preoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively ] [Срок оценки: preoperatively and at at 3 months, 6 months, 1 year and 2 years]

Вторичные конечные точки (7)

• Plain radiographs [ Time Frame: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively ] [Срок оценки: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively]
• Duel energy x-ray absorptiometry (DXA) [ Time Frame: Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively ] [Срок оценки: Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively]
• Constant-Murley score [ Time Frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively ] [Срок оценки: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively]
• Oxford Shoulder Score (OSS) [ Time Frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively ] [Срок оценки: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively]
• Side effects and complications [ Time Frame: 2 years postoperatively ] [Срок оценки: 2 years postoperatively]
• Pain and patient-satisfaction: visual analogue scale (VAS) [ Time Frame: 3 months, 6 months, and at 1 and 2 years postoperatively ] [Срок оценки: 3 months, 6 months, and at 1 and 2 years postoperatively]
• Cost-utility analysis [ Time Frame: 2 years postoperatively ] [Срок оценки: 2 years postoperatively]

Критерии участия

Критерии включения

• Rotator cuff arthropathy defined as degeneration of the glenohumeral joint and wear or tear of at least one rotator cuff tendon
• Degeneration of the glenohumeral joint with intact rotator cuff function but severe posterior wear of the glenoid (>20 degrees posterior wear)
• Insufficient effect of non-surgical treatment with symptoms severe enough to justify shoulder arthroplasty.
• ASA (American Society of Anesthesiology) score 1-3, physically fit for surgery and rehabilitation

Критерии исключения

• Below 50 years of age
• Cognitive or linguistic impairment
• Insufficient glenoid bone-stock
• Previous fracture in the upper extremities
• Patients with autoimmune mediated inflammatory arthritis
• Glenoid border medial to the medial border of the coracoid on a true AP radiograph

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Herlev and Gentofte Hospital — Hellerup

Публикации

• Andersen MR, Winther NS, Lind T, Schroder HM, Flivik G, Petersen MM. Low Preoperative BMD Is Related to High Migration of Tibia Components in Uncemented TKA-92 Patients in a Combined DEXA and RSA Study With 2-Year Follow-Up. J Arthroplasty. 2017 Jul;32(7):2141-2146. doi: 10.1016/j.arth.2017.02.032. Epub 2017 Feb 28. PMID 28410836
• Andersen MR, Winther N, Lind T, SchroDer H, Flivik G, Petersen MM. Monoblock versus modular polyethylene insert in uncemented total knee arthroplasty. Acta Orthop. 2016 Dec;87(6):607-614. doi: 10.1080/17453674.2016.1233654. Epub 2016 Sep 20. PMID 27649258
• Andersen MR, Winther NS, Lind T, Schroder HM, Mork Petersen M. Bone Remodeling of the Distal Femur After Uncemented Total Knee Arthroplasty-A 2-Year Prospective DXA Study. J Clin Densitom. 2018 Apr-Jun;21(2):236-243. doi: 10.1016/j.jocd.2017.05.001. Epub 2017 Sep 13. PMID 28918227
• ten Broeke RH, Hendrickx RP, Leffers P, Jutten LM, Geesink RG. Randomised trial comparing bone remodelling around two uncemented stems using modified Gruen zones. Hip Int. 2012 Jan-Feb;22(1):41-9. doi: 10.5301/HIP.2012.9103. PMID 22383318
• Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available. PMID 18218327
• Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996 Jul;78(4):593-600. PMID 8682827
• Denard PJ, Walch G. Current concepts in the surgical management of primary glenohumeral arthritis with a biconcave glenoid. J Shoulder Elbow Surg. 2013 Nov;22(11):1589-98. doi: 10.1016/j.jse.2013.06.017. Epub 2013 Sep 3. PMID 24007651
• Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335. PMID 22047932

Идентификаторы

NCT: NCT05447819 · H-21042181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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