Anatomic TSA vs RTSA for Glenohumeral Arthritis

Arthritis Shoulder Clinical Trial

Official title:

Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis. A Randomized Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04629391
• Other study ID #: 2019-02471
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2022
• Source: La Tour Hospital
• Contact: Alexandre Lädermann, MD
• Phone: +41 22 719 75 55
• Email: alexandre.laedermann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: September 1, 2023
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis Shoulder

Intervention

Device:
• Total shoulder arthroplasty
A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis.

Locations

Country	Name	City	State
Switzerland	La Tour Hospital	Meyrin

Sponsors (1)

Lead Sponsor	Collaborator
La Tour Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in American Shoulder and Elbow Surgeons score (ASES)	General clinical score (0-100, with 100 being the best score possible)	Between baseline and 2 postoperative years
Secondary	Change in Subjective Shoulder Value (SSV)	General clinical score (0-100, with 100 being the best score possible)	Between baseline and 2 postoperative years
Secondary	Change in Range of motion in degrees	(anterior forward flexion, external rotation at the side, internal rotation to nearest spinal level)	Between baseline and 2 postoperative years
Secondary	Complication rates		2 postoperative years.
Secondary	Change in pain on visual analogic scale (pVAS)	General clinical score (0-10, with 10 the worst score possible)	Between baseline and 2 postoperative years
Secondary	Change in Constant score	General clinical score (0-100, with 100 being the best score possible)	Between baseline and 2 postoperative years
Secondary	Change in Short Form -12 (SF-12)	General clinical score (0-100, with 100 being the best score possible)	Between baseline and 2 postoperative years
Secondary	Radiographic outcomes	Rates of aseptic loosening, implant migration, implant tilt, scapular notching, glenoid bone loss as defined previously by the investigator	2 postoperative years