Reverse Total Shoulder Arthroplasty (RTSA) for Arthrosis
Phase-Based Progress Estimates
Effectiveness
Safety
The Ottawa Hospital, Ottawa, Canada
Arthrosis+1 More
Reverse Total Shoulder Arthroplasty (RTSA) - ProcedureEligibility
65+
All Sexes
What conditions do you have?
Select
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
Other trials for Arthrosis
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
Safety Progress
Other trials for Arthrosis
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: ProcedureTotal Shoulder Arthroplasty (TSA)
Procedure
ActiveComparator Group · 1 Intervention: Total Shoulder Arthroplasty (TSA) · Intervention Types: ProcedureTreatment
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
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 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
- Dines, Joshua S., Stephen Fealy, Eric J. Strauss, Answorth Allen, Edward V. Craig, Russell F. Warren, and David M. Dines. 2006. “Outcomes Analysis of Revision Total Shoulder Replacement”. The Journal of Bone & Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.d.02946.
- Walch, Gilles, Allan A Young, Pascal Boileau, Markus Loew, Dominique Gazielly, and Daniel Molé. 2012. “Patterns of Loosening of Polyethylene Keeled Glenoid Components After Shoulder Arthroplasty for Primary Osteoarthritis”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.j.00699.
- Pandya, Jay, Tamara Johnson, and Adrian K. Low. 2018. “Shoulder Replacement for Osteoarthritis: A Review of Surgical Management”. Maturitas. Elsevier BV. doi:10.1016/j.maturitas.2017.11.013.
- Eichinger, Josef K., and Joseph W. Galvin. 2015. “Management of Complications After Total Shoulder Arthroplasty”. Current Reviews in Musculoskeletal Medicine. Springer Science and Business Media LLC. doi:10.1007/s12178-014-9251-x.
- Walch, Gilles, Roger Badet, Aziz Boulahia, and Alfred Khoury. 1999. “Morphologic Study of the Glenoid in Primary Glenohumeral Osteoarthritis”. The Journal of Arthroplasty. Elsevier BV. doi:10.1016/s0883-5403(99)90232-2.
- Kim, Sunny H, Barton L Wise, Yuqing Zhang, and Robert M Szabo. 2011. “Increasing Incidence of Shoulder Arthroplasty in the United States”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.j.01994.
- Ingram M, Symmons DPM. The burden of musculoskeletal conditions. Medicine. 2018; 46(3):152-155. https://doi.org/10.1016/j.mpmed.2017.12.005
- Stephens, Scott P, Kevin C Paisley, Jeffrey Jeng, Anil K Dutta, and Michael A Wirth. 2015. “Shoulder Arthroplasty in the Presence of Posterior Glenoid Bone Loss”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.n.00566.
- Norris, Tom R., and Joseph P. Iannotti. 2002. “Functional Outcome After Shoulder Arthroplasty for Primary Osteoarthritis: A Multicenter Study”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1067/mse.2002.121146.
- Fink, B., J. M. Strauss, U. Lamla, T. Kurz, H. Guderian, and W. Rüther. 2001. “Endoprosthetic Surface Replacement of the Humeral Head”. Der Orthopäde. Springer Science and Business Media LLC. doi:10.1007/s001320170087.
- VOGT, M, E SIMONSICK, T HARRIS, M NEVITT, J KANG, S RUBIN, S KRITCHEVSKY, and A NEWMAN. 2003. “Neck and Shoulder Pain in 70- to 79-year-old Men and Women: Findings from the Health, Aging and Body Composition Study*1”. The Spine Journal. Elsevier BV. doi:10.1016/s1529-9430(03)00150-5.
- 2022. "Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05395819.
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