Reverse Total Shoulder Arthroplasty (RTSA) for Arthrosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ottawa Hospital, Ottawa, Canada
Arthrosis+1 More
Reverse Total Shoulder Arthroplasty (RTSA) - Procedure
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Arthrosis
  • Osteoarthritis of the Shoulder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 6 weeks, 3-, 6- and 12-months

Week 6
Number of complications
Number of re-admissions
Number of re-operations
Week 6
Change in EuroQol EQ-5D-5L quality of life questionnaire
Change in Shoulder Pain
Change in Shoulder Range of Motion (ROM)
Change in Subjective Shoulder Value (SSV)
Change in The American Shoulder and Elbow Surgeon's (ASES) questionnaire
Change in Western Ontario Osteoarthritis of the Shoulder (WOOS)
Failure
Baseline, 6- and 12-months
Change in Constant Score
Change in Shoulder Strength

Trial Safety

Trial Design

2 Treatment Groups

Total Shoulder Arthroplasty (TSA)
1 of 2
Reverse Total Shoulder Arthroplasty (RTSA)
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Reverse Total Shoulder Arthroplasty (RTSA) · No Placebo Group · N/A

Reverse Total Shoulder Arthroplasty (RTSA)
Procedure
Experimental Group · 1 Intervention: Reverse Total Shoulder Arthroplasty (RTSA) · Intervention Types: Procedure
Total Shoulder Arthroplasty (TSA)
Procedure
ActiveComparator Group · 1 Intervention: Total Shoulder Arthroplasty (TSA) · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reverse Total Shoulder Arthroplasty (RTSA)
2019
N/A
~110

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 3-, 6- and 12-months
Closest Location: The Ottawa Hospital · Ottawa, Canada
Photo of Ottawa  1Photo of Ottawa  2Photo of Ottawa  3
2001First Recorded Clinical Trial
0 TrialsResearching Arthrosis
223 CompletedClinical Trials

Eligibility Criteria

Age 65+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a glenoid deficiency and >15 degrees of retroversion.
You have used drugs including analgesics and non-steroidal anti-inflammatory drugs.
Imaging, and intra-operative findings confirming advanced gleno-humeral cartilage loss.
You have a 65 years of age or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References