Recruiting

TSA vs. RSA

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04228419

Conditions

Osteoarthritis of the Shoulder

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Total Shoulder Arthroplasty

Reverse Shoulder Arthroplasty

Study Details

Brief summary:

This study will compare total shoulder arthroplasty (TSA) reverse shoulder arthroplasty (RSA) procedures, in the context of a prospective, randomized-controlled trial to determine the optimal treatment in patients 65 years of age and older, and equal to or less than 15 degrees of glenoid retroversion, who have glenohumeral osteoarthritis.

Conditions

Osteoarthritis of the Shoulder

Study ID

NCT04228419

Start date

Mar 9, 2020

Status verified date

Mar, 2025

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients who have failed standard non-surgical management of their idiopathic shoulder osteoarthritis 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 6 months. Medical management will be defined as:

1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
2. Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
3. Activity modification
2. Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
3. Patients may present with a glenoid deficiency and </=15 degrees of retroversion
4. 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

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)

TSA procedure involves replacing the worn-out ball and socket joint with prosthetic 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

Replacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components.

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 and 5-Years Post-Operative ]

Central Contacts and Locations

Central contacts

Locations

Kingston General Hospital (Site-Watkins 3)

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Principal Investigator:

Ryan Bicknell, MD

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Peter Lapner, MD

6137378899

Principal Investigator:

Peter Lapner, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 25, 2025

Last verified

Mar, 2025

Keywords

  • 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 2025-03-25.