- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04629391
Anatomic TSA vs RTSA for Glenohumeral Arthritis
Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis. A Randomized Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
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 with a medialized center of rotation to treat cuff tear arthropathy. Favorable early reports led to the expansion of primary indications of RTSA to proximal humeral 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, Steen et al. reported equivalent functional results at >2-year follow-up. The retrospective matched cohort study could, however, not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients. The authors therefore hypothesize that, in patients treated for glenohumeral osteoarthritis without excessive glenoid retroversion, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies confirmed in 2019 Steen's 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. The primary goal of our prospective randomized study is to determine whether 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandre Lädermann, MD
- Phone Number: +41 22 719 75 55
- Email: alexandre.laedermann@gmail.com
Study Locations
-
-
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Meyrin, Switzerland, 1217
- Recruiting
- La Tour Hospital
-
Contact:
- Alexandre Lädermann, MD
- Phone Number: +41 22 719 75 55
- Email: alexandre.laedermann@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary glenohumeral arthritis,
- Intact rotator cuff,
- No important glenoid bone loss (cf exclusion criteria),
- Patients between 65 and 85 years old
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Exclusion Criteria:
- B2 glenoid with > 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
- B3 and C type glenoids,
- Full thickness rotator cuff tear,
- Acute or malunited proximal humeral fracture,
- Chronic locked dislocation
- Rheumatoid arthritis,
- Revision surgery or surgical antecedents,
- Tumors,
- Axillary nerve damage,
- Non-functioning deltoid muscle,
- Glenoid vault deficiency precluding baseplate fixation,
- Infection and neuropathic joints,
- Known or suspected non-compliance, drug or alcohol abuse,
- Patients incapable of judgement or under tutelage,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Anatomic TSA
The control group will receive through a deltopectoral approach an anatomic total shoulder arthroplasty (TSA) for a primary glenohumeral arthritis
|
A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis.
|
|
Experimental: RTSA
The experimental group will receive through a deltopectoral approach a reverse total shoulder arthroplasty RTSA for a primary glenohumeral arthritis
|
A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in American Shoulder and Elbow Surgeons score (ASES)
Time Frame: Between baseline and 2 postoperative years
|
General clinical score (0-100, with 100 being the best score possible)
|
Between baseline and 2 postoperative years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Subjective Shoulder Value (SSV)
Time Frame: Between baseline and 2 postoperative years
|
General clinical score (0-100, with 100 being the best score possible)
|
Between baseline and 2 postoperative years
|
|
Change in Range of motion in degrees
Time Frame: Between baseline and 2 postoperative years
|
(anterior forward flexion, external rotation at the side, internal rotation to nearest spinal level)
|
Between baseline and 2 postoperative years
|
|
Complication rates
Time Frame: 2 postoperative years.
|
2 postoperative years.
|
|
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Change in pain on visual analogic scale (pVAS)
Time Frame: Between baseline and 2 postoperative years
|
General clinical score (0-10, with 10 the worst score possible)
|
Between baseline and 2 postoperative years
|
|
Change in Constant score
Time Frame: Between baseline and 2 postoperative years
|
General clinical score (0-100, with 100 being the best score possible)
|
Between baseline and 2 postoperative years
|
|
Change in Short Form -12 (SF-12)
Time Frame: Between baseline and 2 postoperative years
|
General clinical score (0-100, with 100 being the best score possible)
|
Between baseline and 2 postoperative years
|
|
Radiographic outcomes
Time Frame: 2 postoperative years
|
Rates of aseptic loosening, implant migration, implant tilt, scapular notching, glenoid bone loss as defined previously by the investigator
|
2 postoperative years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandre Lädermann, MD, La Tour Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-02471
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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