RecruitingNot ApplicableNCT05395819

Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis

Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: A Pilot Randomized Control Trial


Sponsor

University of Alberta

Enrollment

40 participants

Start Date

May 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide and it is common in an aging population. Surgical shoulder replacement (arthroplasty) is typically considered when non-surgical measures, such as physiotherapy or medication, have failed. There are two commonly performed surgical replacement procedures in patients who have advanced shoulder OA, and are 65 years of age and older: "Total Shoulder replacement or Arthroplasty (TSA)" and "Reverse Total Shoulder Arthroplasty (RTSA)". Few studies have compared the two procedures. Surgeons face uncertainty regarding which procedure to perform in patients 65 years of age and older. This pilot Randomized Controlled Trial (RCT) will compare the "TSA" and "RTSA" procedures, in patients 65 years of age and older. Participants will be assigned at random, (like flipping a coin), to one of the two groups (TSA or RTSA). The overall goal of this pilot study is to determine which procedure produces better functional and quality of life outcomes with fewer complications within the first 12-months after surgery. Moreover, pilot data will help determining the feasibility of conducting a larger trial comparing TSA versus RTSA surgical management in 65 years of age and older participants with advanced shoulder OA.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of shoulder replacement surgery — reverse shoulder arthroplasty versus anatomic shoulder arthroplasty — for older adults with severe shoulder osteoarthritis who have not improved with non-surgical treatment. You may be eligible if: - You are 65 years of age or older - You have shoulder osteoarthritis that has not improved after at least 6 months of non-surgical treatment (medications, physiotherapy, activity changes) - Imaging confirms advanced cartilage loss in your shoulder joint - Your surgeon confirms you are a candidate for shoulder replacement You may NOT be eligible if: - You have an active infection in the joint or elsewhere - You have rotator cuff arthropathy - You have had previous shoulder surgery on the affected side - You have a major medical illness with less than 1 year life expectancy - You have significant muscle paralysis or Charcot's arthropathy - You are unable to provide informed consent or have psychiatric illness affecting consent - You are unwilling to be followed for the study duration Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREReverse Total Shoulder Arthroplasty (RTSA)

Patient will undergo a RTSA as per standard technique. It uses a stemmed metal humeral component attached to the glenoid and the shallow glenoid component attached to the humerus. Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within \< 10 degrees of neutral glenoid version. Standard instruments including a spherical burr and power reamers will be used to achieve this.

PROCEDURETotal Shoulder Arthroplasty (TSA)

Patients will undergo standard glenoid preparation and implantation of a TSA. It uses a stemmed metal humeral component to replace the arthritic head of humerus and a shallow polyethylene glenoid component to replace the arthritic glenoid surface. The degree of anterior- reaming will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.


Locations(8)

Royal Alexandra Hospital (Orthopaedic Surgical Centre)

Edmonton, Alberta, Canada

Glen Sather Sports Medicine Clinic (University of Alberta)

Edmonton, Alberta, Canada

Kaye Edmonton Clinic

Edmonton, Alberta, Canada

Collaborative Orthopaedic Research (CORe), Clinical Sciences Building

Edmonton, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Sturgeon Community Hospital

St. Albert, Alberta, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

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NCT05395819


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