Clinical trial NCT06513559: Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis
Official title: Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis: a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glenohumeral Osteoarthritis
Keywords: glenohumeral osteoarthritis
reverse total shoulder arthroplasty
anatomic replacement
reverse replacement
range of motion
pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 patients.The 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.

Eligibility criteria: Inclusion Criteria:

* Primary glenohumeral arthritis,
* Intact rotator cuff,
* No important glenoid bone loss (cf exclusion criteria),
* Patients between 60 and 85 years old (based on indications for RTSA)
* 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,

Primary outcomes:
measure: American Shoulder and Elbow Surgeons score
timeFrame: date of surgery
measure: American Shoulder and Elbow Surgeons score
timeFrame: 6 months after date of surgery
measure: American Shoulder and Elbow Surgeons score
timeFrame: 12 months after date of surgery
measure: American Shoulder and Elbow Surgeons score
timeFrame: 24 months after date of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopedics
state: Utah
Study officials:
affiliation: University of Utah Orthopaedics
name: Christopher Joyce, M.D.
role: PRINCIPAL_INVESTIGATOR
References: