Recruiting

TSA vs. RSA

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05487274

Conditions

Osteoarthritis Shoulder

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Total Shoulder Arthroplasty + augmented glenoid component

Reverse Shoulder Arthroplasty

Study Details

Brief summary:

This study will compare total shoulder arthroplasty (TSA) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a prospective, randomized controlled trial to determine the optimal treatment in this patient population.

Conditions

Osteoarthritis Shoulder

Study ID

NCT05487274

Start date

Aug 9, 2022

Status verified date

Apr, 2024

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of idiopathic shoulder OA.
2. Patients who have failed standard non-surgical management of their shoulder OA who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for at least 6 months. Medical management will be defined as: a) The use of drugs including analgesics and nonsteroidal anti-inflammatory drugs, b) Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.), c) Activity modification
3. Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
4. Patients with a glenoid deficiency and >15 degrees of glenoid retroversion up to a maximum of 26 degrees of glenoid retroversion (i.e. -15.1, -17, -20...etc.)
5. 65 years of age and older

Exclusion Criteria:

1. Active joint or systemic infection
2. Rotator cuff arthropathy
3. Significant muscle paralysis
4. Charcot's arthropathy
5. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
6. Unable to understand the consent form/process
7. Pregnancy
8. Psychiatric illness that precludes informed consent
9. Unwilling to be followed for the duration of the study
10. Retroversion cannot be surgically corrected to within 10 degrees of neutral
11. History of previous shoulder surgery on affected side
12. Rheumatoid arthritis in the affected shoulder

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Total Shoulder Arthroplasty (anatomic) + augmented glenoid component

TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. An additional surgical technique, "augmented glenoid component" implantation is performed when there is missing bone in the shoulder and is currently being done as standard of care. This technique is used particularly when a large amount of instability within the shoulder joint is present. This technique attempts to realign and restore balance to the shoulder joint using artificial components.

active comparator: Reverse Shoulder Arthroplasty

RSA procedure is similar to a TSA, however the orientation of the ball and socket joint is placed in the reverse position

Interventions

Total Shoulder Arthroplasty + augmented glenoid component

Replacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components. A prosthetic component is also implanted to correct for the amount of bone loss in the shoulder and restore stability.

Reverse Shoulder Arthroplasty

Replacement of the shoulder joint like the TSA, however the orientation of the ball and socket is reversed.

Primary outcome measure

  • Western Ontario Osteoarthritis of the Shoulder Index (WOOS) [ Time Frame: 24-Months Post-Operative ]
  • Western Ontario Osteoarthritis of the Shoulder Index (WOOS) [ Time Frame: 5-Years Post-Operative ]

Central Contacts and Locations

Central contacts

Locations

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Principal Investigator:

Peter Lapner, MD FRCSC

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 30, 2024

Last verified

Apr, 2024

Keywords

  • Shoulder Arthroplasty
  • Glenohumeral Osteoarthritis
  • Idiopathic Osteoarthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-04-30.