Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513559
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis A Randomized Prospective Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty RTSA have at least as good results as anatomic TSA non-inferiority in patients with glenohumeral osteoarthritis without rotator cuff tears nor significant glenoid retroversion
The secondary goals are 1 to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA superiority 2 to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA
The devices being used in the research are an Arthrex Universe system Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid They are FDA approved commonly used and used as indicated The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side
In all cases a deltopectoral incision will be used as the procedure type
The secondary goals are 1 to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA superiority 2 to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA
The devices being used in the research are an Arthrex Universe system Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid They are FDA approved commonly used and used as indicated The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side
In all cases a deltopectoral incision will be used as the procedure type
Detailed Description:
Total anatomic shoulder arthroplasty TSA is an effective treatment of severe glenohumeral osteoarthritis with significant improvement in shoulder pain and function Concerns about glenoid loosening associated with difficult revision procedures and disappointing outcomes have however been raised
Reverse total shoulder arthroplasty RTSA was designed to treat cuff tear arthropathy Favorable early reports led to the expansion of using RTSA to treat other shoulder fractures as well as osteoarthritis with poor glenoid bone stock Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications
Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score ASES at 2-year follow-up In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs investigators have reported equivalent functional results at 2-year follow-up However this study could not eliminate biases such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patientsThe investigators therefore hypothesize that in patients treated for glenohumeral osteoarthritis RTSA will render better functional outcomes than anatomic TSA at 2 postoperative years Many other studies have confirmed this hypothesis Moreover several studies revealed good long-term survivorship after RTSA
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion
Reverse total shoulder arthroplasty RTSA was designed to treat cuff tear arthropathy Favorable early reports led to the expansion of using RTSA to treat other shoulder fractures as well as osteoarthritis with poor glenoid bone stock Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications
Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score ASES at 2-year follow-up In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs investigators have reported equivalent functional results at 2-year follow-up However this study could not eliminate biases such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patientsThe investigators therefore hypothesize that in patients treated for glenohumeral osteoarthritis RTSA will render better functional outcomes than anatomic TSA at 2 postoperative years Many other studies have confirmed this hypothesis Moreover several studies revealed good long-term survivorship after RTSA
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None