TSA vs RSA in Glenohumeral Osteoarthritis
ConditionOsteoarthritis of the Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorOttawa Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Active joint or systemic infection
Rotator cuff arthropathy
Significant muscle paralysis
Charcot's arthropathy
Trial design
Design model
Parallel
Treatments tested in this trial
Total Shoulder Arthroplasty
Procedure/SurgeryReplacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components.
Reverse Shoulder Arthroplasty
Procedure/SurgeryReplacement of the shoulder joint like the TSA, however the orientation of the ball and socket is reversed.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Total Shoulder Arthroplasty (anatomic)Active comparator 1 intervention
Group B: Reverse Shoulder ArthroplastyActive comparator 1 intervention
Trial outcomes
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.
Time frame
24-Months and 5-Years Post-OperativeSecondary outcomes
1
Standard CT Scans
Radiological parameters will be examined using Computed Tomography (CT). These scans will be analyzed for abnormalities in component alignment, and evidence of lucencies or loosening. Higher incidence of loosening, or noted abnormalities will be compared between groups. A higher incidence indicates worse outcomes.
Time frame
24-Months and 5-Years Post-Operative2
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Time frame
24-Months and 5-Years Post-Operative3
Pain Level
Subjective pain value of the shoulder will be assessed using a questionnaire. Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. The higher the score, the worse the outcome.
Time frame
24-Months and 5-Years Post-Operative4
Subjective Shoulder Value
A participant's subjective value on shoulder function will be assessed using a questionnaire. The overall functional value of the shoulder is written as a percentage from 0-100% of a normal shoulder. The higher the score, the better the outcome.
Time frame
24-Months and 5-Years Post-OperativeSponsors and contacts
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Source ClinicalTrials.gov