TSA vs RSA in Glenohumeral Osteoarthritis

NCT ID: NCT04228419

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2032-12-31

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.

Detailed Description

Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can be the cause of pain and dysfunction and is a growing occurrence in the investigator's aging population. TSA or RSA are common surgical procedures used to treat patients with shoulder OA. TSA is able to keep the "natural anatomy" of the shoulder and involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent, particularly when the arthritis is associated with bone erosion on the glenoid (socket).

RSA is an alternative surgical procedure commonly used and involves replacing and reversing the ball and the socket (i.e. opposite of TSA). RSA is typically performed in patients with a rotator cuff deficiency and more severe OA. Though RSA procedures show marked increase in clinical and functional outcomes, evidence of its long-term results are sparse, and as such is typically reserved for when treating an older patient population.

Few research studies have compared these different surgical techniques to one another, in the older patient population.

This research will provide surgeons with new information regarding the best treatment for patients in this population.

This Randomized Controlled Trial (RCT) will compare TSA and RSA procedures in those 65 years of age and older, who have equal to or less than 15 degrees of glenoid retroversion, in an effort to determine which approach produces better functional outcomes and improved quality of life in this patient population.

Primary Objective: Determine the difference in disease specific quality of life between patients diagnosed with glenohumeral OA who undergo either a TSA or RSA as measured by the Western Osteoarthritis of the Shoulder (WOOS) score at 24-months and 5-years post-operative.

Secondary Objectives: i) Determine the difference in disease specific quality of life between patients diagnosed with a glenohumeral osteoarthritis who undergo a shoulder replacement with RSA or TSA as measured by the Constant score, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES), the EuroQol Group EQ-5D-5L score, pain (using a Visual Analog Scale), and Subjective Shoulder Value (SSV) at 24-months and 5-years post-operative as well as adverse events, and health care utilization.

ii) To determine the survivorship of the components as measured by the degree of radiographic lucencies and component alignment determined by a CT scan at 1- and 5-years post-surgery.

Clinical Relevance: Shoulder OA results in pain and dysfunction, which negatively impacts quality of life. As such, determination of superior treatment approach will lead to significant improvement in quality of life, and cost savings through avoidance of recurrence and/or reoperation, as well as decreased morbidity for patients in this population.

Conditions

Osteoarthritis of the Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Total Shoulder Arthroplasty (anatomic)

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

Group Type: ACTIVE_COMPARATOR

Total Shoulder Arthroplasty

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

Reverse Shoulder Arthroplasty

Intervention Type: PROCEDURE

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

Interventions

Total Shoulder Arthroplasty

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

Intervention Type: PROCEDURE

Reverse Shoulder Arthroplasty

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Lapner, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

University of Alberta

Edmonton, Alberta, Canada

Site Status: NOT_YET_RECRUITING

Pan Am Clinic Foundation

Winnipeg, Manitoba, Canada

Site Status: NOT_YET_RECRUITING

Kingston General Hospital (Site-Watkins 3)

Kingston, Ontario, Canada

Site Status: RECRUITING

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Peter Lapner Lapner, MD

Role: CONTACT

plapner@toh.ca

613-737-8899 ext. 78377

Katie McIlquham

Role: CONTACT

kmcilquham@ohri.ca

613-737-8899 ext. 79839

Facility Contacts

Martin Bouliane, MD

Role: primary

780-434-4859

Sheila McRae

Role: primary

204-925-7469

Fiona Howells

Role: primary

fiona.howells@queensu.ca

613-549-6666 ext. 4348

Peter Lapner, MD

Role: primary

6137378899 ext. 78377

Other Identifiers

20190674-01H

Identifier Type: -

Identifier Source: org_study_id