- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04728282
Comparison of Lateralized RTSA With and Without Subscapularis Repair
Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main objective of this study is to compare patient-reported outcome measures (PROMs), and clinical and functional outcomes between RTSA with and without subscapularis repair. The specific aims for this study are:
Specific Aim 1:
To determine if there is a difference in PROM scores between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 2:
To determine if there is a difference between the two surgical approaches with respect to shoulder function, specifically range of motion and strength, during the 24-month postoperative period.
Specific Aim 3:
To determine if there is a difference in shoulder dislocation rates between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 4:
To determine if there is a difference in surgical complications, re-operation or revision rates between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 5:
To quantify the operative times for RTSA with and without subscapularis repair, and determine if there is a difference between the two approaches.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Derek McLennan, BSc
- Phone Number: 204-927-2828
- Email: dmclennan@panamclinic.com
Study Contact Backup
- Name: Sheila McRae, PhD
- Phone Number: 204-925-7469
- Email: smcrae@panamclinic.com
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3M 3E4
- Recruiting
- Pan Am Clinic
-
Contact:
- Sheila McRae, PhD
- Phone Number: 204-925-7469
- Email: smcrae@panamclinic.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
- Avascular necrosis
- Post-infectious arthritis
- Proximal humerus fracture
- Inflammatory arthritis
- Inability to communicate in English
- Unable to return for study visits to 24-months post-operative (e.g. unable to arrange transportation to study appointments, plans to relocate, etc.)
Intra-operative Exclusions:
- Subscapularis with fatty infiltration (Goutallier ≥ 3)
- Subscapularis that is deemed to be irreparable. An irreparable tendon is defined as one that is not of sufficient quality or does not allow adequate excursion to reach the repair site
- Any anatomical or patient characteristic that warrants a non-lateralized implant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RTSA with subscapularis repair
|
Lateralized reverse total shoulder arthroplasty with repair of subscapularis
|
Active Comparator: RTSA without subscapularis repair
|
Lateralized reverse total shoulder arthroplasty without repair of subscapularis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ASES Score
Time Frame: 24 months post-operative
|
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.
|
24 months post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Constant Score
Time Frame: baseline pre-operative
|
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.
|
baseline pre-operative
|
Constant Score
Time Frame: 3 months post-operative
|
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.
|
3 months post-operative
|
Constant Score
Time Frame: 6 months post-operative
|
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.
|
6 months post-operative
|
Constant Score
Time Frame: 12 months post-operative
|
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.
|
12 months post-operative
|
Constant Score
Time Frame: 24 months post-operative
|
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.
|
24 months post-operative
|
SANE Score
Time Frame: baseline pre-operative
|
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019).
Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
|
baseline pre-operative
|
SANE Score
Time Frame: 3 months post-operative
|
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019).
Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
|
3 months post-operative
|
SANE Score
Time Frame: 6 months post-operative
|
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019).
Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
|
6 months post-operative
|
SANE Score
Time Frame: 12 months post-operative
|
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019).
Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
|
12 months post-operative
|
SANE Score
Time Frame: 24 months post-operative
|
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019).
Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
|
24 months post-operative
|
EQ5D-3L
Time Frame: baseline, pre-operative
|
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011).
A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population.
There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive.
The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
|
baseline, pre-operative
|
EQ5D-3L
Time Frame: 3 months, post-operative
|
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011).
A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population.
There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive.
The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
|
3 months, post-operative
|
EQ5D-3L
Time Frame: 6 months, post-operative
|
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011).
A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population.
There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive.
The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
|
6 months, post-operative
|
EQ5D-3L
Time Frame: 12 months, post-operative
|
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011).
A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population.
There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive.
The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
|
12 months, post-operative
|
EQ5D-3L
Time Frame: 24 months, post-operative
|
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011).
A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population.
There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive.
The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
|
24 months, post-operative
|
Range of Motion
Time Frame: baseline, pre-surgery
|
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
|
baseline, pre-surgery
|
Range of Motion
Time Frame: 3 months, post-operative
|
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
|
3 months, post-operative
|
Range of Motion
Time Frame: 6 months, post-operative
|
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
|
6 months, post-operative
|
Range of Motion
Time Frame: 12 months, post-operative
|
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
|
12 months, post-operative
|
Range of Motion
Time Frame: 24 months, post-operative
|
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
|
24 months, post-operative
|
Isometric Strength
Time Frame: baseline, pre-surgery
|
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
|
baseline, pre-surgery
|
Isometric Strength
Time Frame: 3 months, post-operative
|
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
|
3 months, post-operative
|
Isometric Strength
Time Frame: 6 months, post-operative
|
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
|
6 months, post-operative
|
Isometric Strength
Time Frame: 12 months, post-operative
|
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
|
12 months, post-operative
|
Isometric Strength
Time Frame: 24 months, post-operative
|
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
|
24 months, post-operative
|
ASES Score
Time Frame: baseline, pre-operative
|
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.
|
baseline, pre-operative
|
ASES Score
Time Frame: 3 months, post-operative
|
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.
|
3 months, post-operative
|
ASES Score
Time Frame: 6 months, post-operative
|
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.
|
6 months, post-operative
|
ASES Score
Time Frame: 12 months, post-operative
|
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.
|
12 months, post-operative
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jarret Woodmass, MD, Pan Am Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSASUB-16-01-2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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