TSA vs RSA in Glenohumeral Osteoarthritis

NCT04228419 | Recruiting

• 1 other identifier: 20190674-01H
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

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

Keywords

arthroplasty; glenohumeral osteoarthritis; idiopathic osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 and 5-Years Post-Operative

Secondary Outcomes (8)

• Standard CT Scans

  24-Months and 5-Years Post-Operative

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

  24-Months and 5-Years Post-Operative

• Pain Level

  24-Months and 5-Years Post-Operative

• Subjective Shoulder Value

  24-Months and 5-Years Post-Operative

• EuroQol EQ-5D-5L

  24-Months and 5-Years Post-Operative

Study Arms (2)

Total Shoulder Arthroplasty (anatomic)

ACTIVE COMPARATOR

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

Procedure: Total Shoulder Arthroplasty

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 PROCEDURE

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

Total Shoulder Arthroplasty (anatomic)

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:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (4)

University of Alberta

Edmonton, Alberta, T6G2G3, Canada

NOT YET RECRUITING

Pan Am Clinic Foundation

Winnipeg, Manitoba, R3M3E4, Canada

NOT YET RECRUITING

Kingston General Hospital (Site-Watkins 3)

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

The Ottawa Hospital

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

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lapner Lapner, MD

CONTACT

613-737-8899; plapner@toh.ca

Katie McIlquham

CONTACT

613-737-8899; kmcilquham@ohri.ca

Study Design

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

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 14, 2020
• Study Start: March 9, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)