Arthritis Shoulder
Conditions
Keywords
shoulder, primary osteoarthritis, Range of motion, clinical outcomes, radiographic outcomes, anatomic prosthesis, reverse prosthesis, Arthroplasty
Brief summary
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.
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.
Interventions
DEVICETotal shoulder arthroplasty
A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis.
Sponsors
La Tour Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
While the patients and care providers will be aware of the type of prosthesis, the physicians who assessed the outcomes and analyzed the data will be blinded to this information.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in American Shoulder and Elbow Surgeons score (ASES) | Between baseline and 2 postoperative years | General clinical score (0-100, with 100 being the best score possible) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subjective Shoulder Value (SSV) | Between baseline and 2 postoperative years | General clinical score (0-100, with 100 being the best score possible) |
| Change in Range of motion in degrees | Between baseline and 2 postoperative years | (anterior forward flexion, external rotation at the side, internal rotation to nearest spinal level) |
| Complication rates | 2 postoperative years. | — |
| Change in pain on visual analogic scale (pVAS) | Between baseline and 2 postoperative years | General clinical score (0-10, with 10 the worst score possible) |
| Change in Constant score | Between baseline and 2 postoperative years | General clinical score (0-100, with 100 being the best score possible) |
| Change in Short Form -12 (SF-12) | Between baseline and 2 postoperative years | General clinical score (0-100, with 100 being the best score possible) |
| Radiographic outcomes | 2 postoperative years | Rates of aseptic loosening, implant migration, implant tilt, scapular notching, glenoid bone loss as defined previously by the investigator |
Countries
Switzerland
Contacts
CONTACTAlexandre Lädermann, MD
PRINCIPAL_INVESTIGATORAlexandre Lädermann, MD
La Tour Hospital
Outcome results
None listed