Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System
NCT ID: NCT05447819
Last Updated: 2024-10-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
122 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-08-01
Study Completion Date
2027-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Based on the sample calculation the investigators intend to include a total number of 122 patients of which the first 56 patients will be studied using MB-RSA and DXA. The patients are allocated into two groups of equal of size:
1. DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group)
2. Standard DELTA Xtend Reverse Shoulder System (control group).
1. DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group)
2. Standard DELTA Xtend Reverse Shoulder System (control group).
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
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
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
Study Groups
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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
Group Type
EXPERIMENTAL
Reverse shoulder arthroplsaty
Intervention Type
PROCEDURE
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
Standard DELTA Xtend Reverse Shoulder System
A design with a standard glenosphere is currently regarded as the standard treatment
Group Type
ACTIVE_COMPARATOR
Reverse shoulder arthroplsaty
Intervention Type
PROCEDURE
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
Interventions
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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
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
1. Rotator cuff arthropathy defined as degeneration of the glenohumeral joint and wear or tear of at least one rotator cuff tendon
2. Degeneration of the glenohumeral joint with intact rotator cuff function but severe posterior wear of the glenoid (\>20 degrees posterior wear)
3. Insufficient effect of non-surgical treatment with symptoms severe enough to justify shoulder arthroplasty.
4. ASA (American Society of Anesthesiology) score 1-3, physically fit for surgery and rehabilitation
2. Degeneration of the glenohumeral joint with intact rotator cuff function but severe posterior wear of the glenoid (\>20 degrees posterior wear)
3. Insufficient effect of non-surgical treatment with symptoms severe enough to justify shoulder arthroplasty.
4. ASA (American Society of Anesthesiology) score 1-3, physically fit for surgery and rehabilitation
Exclusion Criteria
1. Below 50 years of age
2. Cognitive or linguistic impairment
3. Insufficient glenoid bone-stock
4. Previous fracture in the upper extremities
5. Patients with autoimmune mediated inflammatory arthritis
6. Glenoid border medial to the medial border of the coracoid on a true AP radiograph
2. Cognitive or linguistic impairment
3. Insufficient glenoid bone-stock
4. Previous fracture in the upper extremities
5. Patients with autoimmune mediated inflammatory arthritis
6. Glenoid border medial to the medial border of the coracoid on a true AP radiograph
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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DePuy Synthes
INDUSTRY
Sponsor Role
collaborator
Herlev and Gentofte Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Marie Louise Jensen
Principal investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Herlev and Gentofte Hospital
Hellerup, Denmark, Denmark
Site Status
RECRUITING
Countries
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Denmark
Central Contacts
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Facility Contacts
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References
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Winther N, Jensen C, Petersen M, Lind T, Schroder H, Petersen M. Changes in bone mineral density of the proximal tibia after uncemented total knee arthroplasty. A prospective randomized study. Int Orthop. 2016 Feb;40(2):285-94. doi: 10.1007/s00264-015-2852-1. Epub 2015 Jul 17.
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BACKGROUND
Other Identifiers
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H-21042181
Identifier Type: -
Identifier Source: org_study_id
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