TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion

NCT05487274 | Recruiting

• 1 other identifier: 20220449-01H
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

Shoulder Arthroplasty; Glenohumeral Osteoarthritis; Idiopathic Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Western Ontario Osteoarthritis of the Shoulder Index (WOOS)

  The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.

  24-Months Post-Operative

• Western Ontario Osteoarthritis of the Shoulder Index (WOOS)

  The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.

  5-Years Post-Operative

Secondary Outcomes (14)

• Standard CT Scans

  24-Months Post-Operative

• Standard CT Scans

  5-Years Post-Operative

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)

  24-Months Post-Operative

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)

  5-Years Post-Operative

• Pain Level

  24-Months Post-Operative

Study Arms (2)

Total Shoulder Arthroplasty (anatomic) + augmented glenoid component

ACTIVE COMPARATOR

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.

Procedure: Total Shoulder Arthroplasty + augmented glenoid component

Reverse Shoulder Arthroplasty

ACTIVE COMPARATOR

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

Procedure: Reverse Shoulder Arthroplasty

Interventions

Total Shoulder Arthroplasty + augmented glenoid component PROCEDURE

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.

Total Shoulder Arthroplasty (anatomic) + augmented glenoid component

Reverse Shoulder Arthroplasty PROCEDURE

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

Reverse Shoulder Arthroplasty

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic shoulder OA.
• 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
• Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
• 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.)
• years of age and older

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Shoulder

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Peter Lapner, MD FRCSC

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie McIlquham

CONTACT

613-737-8899; kmcilquham@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 4, 2022
• Study Start: August 9, 2022
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)