Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Herlev and Gentofte Hospital
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Radiostereometric analysis (RSA) [ Time Frame: Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively ]
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
It is not possible to blind the observer when implant migration is evaluated using RSA. The patient-reported outcomes are solely evaluated by the patients before the follow-up examination without involving surgeons or observer
Blinding of the patients:
The patients will be blinded to their allocated treatment the first two years after surgery.
Blinding of Statistician:
The randomization is blinded to the statistician who perform the analysis
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension
By using a lateralized glensphere complications can be reduced and patients can achieve an improved outcome.
Currently, little is known about the results of the lateralized design. The initial results have been promising, but migration and eventually loosening of the prosthesis can lead to poor results and, in some cases, revision
Intervention: Reverse shoulder arthroplsaty (Procedure)
Standard DELTA Xtend Reverse Shoulder System
A design with a standard glenosphere is currently regarded as the standard treatment
Intervention: Reverse shoulder arthroplsaty (Procedure)
Outcomes
Primary Outcomes
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
A special x-ray examination technique based upon insertion of small metal beads into the bone surrounding an implant and attachment of beads to the prosthesis (or using 3-dimensional models of the implant (CAD models) = model-based RSA (MB-RSA)). In this way, implant migration can be measured extremely accurate.
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
The WOOS is a disease-specific patient-reported outcome (Lo IK et al 2001). There are 19 questions divided into four domains: Physical symptoms, sports and work, lifestyle and emotions. Each question is answered on a visual analogue scale ranging from 0 to 100. The overall score ranges from 0 to 1900, with 1900 being the worst. For ease of interpretation, the scores are converted to a percentage of the maximum score. There will be used a Danish version of WOOS (Rasmussen JV et al 2013) which was translated according to the guidelines of Guillemin, Bombardier and Beaton (Guillemin F et al 1993). It was validated with classical test theory in a cohort of patients treated with shoulder arthroplasty for osteoarthritis.
Secondary Outcomes
- Plain radiographs [ Time Frame: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively ](Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively)
- Cost-utility analysis [ Time Frame: 2 years postoperatively ](2 years postoperatively)
- Oxford Shoulder Score (OSS) [ Time Frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively ](Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively)
- Side effects and complications [ Time Frame: 2 years postoperatively ](2 years postoperatively)
- Pain and patient-satisfaction: visual analogue scale (VAS) [ Time Frame: 3 months, 6 months, and at 1 and 2 years postoperatively ](3 months, 6 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 ](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 ](Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively)
Investigators
Marie Louise Jensen
Principal investigator
Herlev and Gentofte Hospital