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Recruiting NCT05447819

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

No phase Interventional Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reverse shoulder arthroplsaty.
Who it may be relevant to
Registry conditions: Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure 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

Primary outcome measures

  • Radiostereometric analysis (RSA) [ Time Frame: Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively ] [Time frame: 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 ] [Time frame: preoperatively and at at 3 months, 6 months, 1 year and 2 years]
Secondary outcome measures (7)
  • Plain radiographs [ Time Frame: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively ] [Time frame: 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 ] [Time frame: 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 ] [Time frame: 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 ] [Time frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively]
  • Side effects and complications [ Time Frame: 2 years postoperatively ] [Time frame: 2 years postoperatively]
  • Pain and patient-satisfaction: visual analogue scale (VAS) [ Time Frame: 3 months, 6 months, and at 1 and 2 years postoperatively ] [Time frame: 3 months, 6 months, and at 1 and 2 years postoperatively]
  • Cost-utility analysis [ Time Frame: 2 years postoperatively ] [Time frame: 2 years postoperatively]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Herlev and Gentofte Hospital — Hellerup

Publications

  • 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

Identifiers

NCT: NCT05447819 · H-21042181

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗