Comparison of Lateralized RTSA With and Without Subscapularis Repair
ConditionArthritis Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPanam Clinic
About this trial
The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA
First RTSA implantation
Absence of neoplastic diseases at the treated site
Fatty infiltration of the subscapularis is low-grade (i.e. Goutallier < Grade 3) based on pre-operative CT performed as standard of care in the patient group
Disqualifiers
Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
Avascular necrosis
Post-infectious arthritis
Proximal humerus fracture
Trial design
Design model
Parallel
Treatments tested in this trial
RTSA with subscapularis repair
Procedure/SurgeryLateralized reverse total shoulder arthroplasty with repair of subscapularis
RTSA without subscapularis repair
Procedure/SurgeryLateralized reverse total shoulder arthroplasty without repair of subscapularis
Treatment groups
284 Participants
are divided into 2 treatment groupsGroup A: RTSA with subscapularis repairExperimental treatment 1 intervention
Group B: RTSA without subscapularis repairActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
Time frame
24 months post-operativeSecondary outcomes
1
Constant Score
The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Time frame
baseline pre-operative2
Constant Score
The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Time frame
3 months post-operative3
Constant Score
The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Time frame
6 months post-operative4
Constant Score
The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Time frame
12 months post-operativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Panam Clinic
Lead sponsor
University of Manitoba
Collaborator
Source ClinicalTrials.gov