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 pilot randomized trial is comparing two surgical approaches for shoulder replacement in adults aged 65 and older with advanced shoulder osteoarthritis: Total Shoulder Arthroplasty (TSA), the traditional procedure, versus Reverse Total Shoulder Arthroplasty (RTSA), a newer design. Surgeons are uncertain which procedure gives better long-term function and fewer complications in older patients, and this pilot study will help determine if a larger definitive trial is feasible. Adults 65 and older who have failed at least 6 months of non-surgical treatments (medication, physiotherapy, activity modification) and have advanced cartilage damage confirmed on imaging are eligible — those with active infection, rotator cuff arthropathy, significant muscle paralysis, or previous shoulder surgery on the affected side are not. Participation involves being randomly assigned to one of the two surgeries and attending follow-up visits at 6 weeks, 3, 6, and 12 months for shoulder function testing and questionnaires. This summary was prepared with AI assistance to help patients understand the study in plain language.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05395819


Related Trials