Back to resultsRC Repair Versus Subacromial Balloon Spacer in Older Adults
Primary Purpose
Rotator Cuff Tears
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subacromial spacer implantation
Rotator cuff repair
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears focused on measuring rotator cuff repair, subacromial spacer, older adults
Eligibility Criteria
Inclusion Criteria: 70 years of age or older clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear >2cm or more than 1 full tendon ongoing symptoms after 3 months of physiotherapy a tendon amenable to partial or complete repair (as determined by pre-operative MRI) absence glenohumeral arthritis (Hamada < 3) absence of neoplastic diseases at treated site Exclusion Criteria: previous surgery or pseudoparalysis on study shoulder complete subscapularis deficiency external rotation lag signs avascular necrosis post-infectious arthritis proximal humerus fracture inflammatory arithritis axillary nerve palsy concomitant tendon transfer neuromuscular disorder unable to speak/read English Intra-operative Exclusion: -tendon is NOT amenable to partial or complete repair
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Subacromial spacer implantation
Rotator Cuff Repair
Arm Description
Outcomes
Primary Outcome Measures
Study feasibility - randomized
Percentage of patients randomized
Study feasibility - recruitment
Number of screened patients and proportion that are deemed eligible that consent
Study feasibility - surgery
Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.
Secondary Outcome Measures
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.
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
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
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
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
EQ5D-3L
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.
EQ5D-3L
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.
EQ5D-3L
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.
EQ5D-3L
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.
EQ5D-3L
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.
SANE Score
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)?"
SANE Score
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)?"
SANE Score
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)?"
SANE Score
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)?"
SANE Score
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)?"
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.
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.
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.
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.
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.
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Full Information
NCT ID
NCT05788250
First Posted
February 1, 2023
Last Updated
March 27, 2023
Sponsor
Panam Clinic
Collaborators
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT05788250
Brief Title
RC Repair Versus Subacromial Balloon Spacer in Older Adults
Official Title
Randomized Clinical Trial Comparing Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Panam Clinic
Collaborators
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot study is to assess the feasibility of a full randomized trial design.
Detailed Description
The feasibility objectives are:
Recruitment
To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent.
To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears.
Surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups.
Clinical objectives for observational purposes only are as follows:
Patient reported and clinical outcomes.
Number of "failures" in each group (defined as additional surgery and/or having <12% improvement in SANE score from baseline).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
rotator cuff repair, subacromial spacer, older adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This a double-blind (patient and assessor), parallel, 1:1 multicentre randomized pilot study comparing patients 70 years and older randomized to SBS or RCR. 32 participants from eight orthopaedic surgeons at four sites will be recruited over a one-year period. Randomization will be generated using a web-based system pre-operatively and stratified to ensure 8 medium/large tears and 8 massive tears are allocated to each group.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients will be blinded to their group allocation. This is possible because the incision and rehabilitation processes are consistent between groups. It is not possible for the treating surgeon to be blinded to group allocation, therefore a research team member (athletic or physical therapist) will remain blinded to group allocation and conduct all study related assessments as well as administer the patient-reported questionnaires. This will be maintained by the participant not removing their shirt during the study assessment. Patients will not be informed of which procedure they will undergo until the study is complete.
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subacromial spacer implantation
Arm Type
Experimental
Arm Title
Rotator Cuff Repair
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Subacromial spacer implantation
Intervention Description
A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.
Intervention Type
Procedure
Intervention Name(s)
Rotator cuff repair
Intervention Description
Rotator cuff repair with tenotomy of long head of biceps.
Primary Outcome Measure Information:
Title
Study feasibility - randomized
Description
Percentage of patients randomized
Time Frame
1 year
Title
Study feasibility - recruitment
Description
Number of screened patients and proportion that are deemed eligible that consent
Time Frame
1 year
Title
Study feasibility - surgery
Description
Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
ASES Score
Description
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
Baseline, pre-operative
Title
ASES Score
Description
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
3 Months, post-operative
Title
ASES Score
Description
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
6 Months, post-operative
Title
ASES Score
Description
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
12 Months, post-operative
Title
ASES Score
Description
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-operative
Title
EQ5D-3L
Description
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.
Time Frame
Baseline, pre-operative
Title
EQ5D-3L
Description
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.
Time Frame
3 Months, post-operative
Title
EQ5D-3L
Description
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.
Time Frame
6 Months, post-operative
Title
EQ5D-3L
Description
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.
Time Frame
12 Months, post-operative
Title
EQ5D-3L
Description
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.
Time Frame
24 Months, post-operative
Title
SANE Score
Description
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)?"
Time Frame
Baseline, pre-operative
Title
SANE Score
Description
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)?"
Time Frame
3 Months, post-operative
Title
SANE Score
Description
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)?"
Time Frame
6 Months, post-operative
Title
SANE Score
Description
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)?"
Time Frame
12 Months, post-operative
Title
SANE Score
Description
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)?"
Time Frame
24 Months, post-operative
Title
Constant Score
Description
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-operative
Title
Constant Score
Description
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-operative
Title
Constant Score
Description
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-operative
Title
Constant Score
Description
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-operative
Title
Constant Score
Description
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
24 Months, post-operative
Title
Range of Motion
Description
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Time Frame
Baseline, pre-operative
Title
Range of Motion
Description
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Time Frame
3 Months, post-oeprative
Title
Range of Motion
Description
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Time Frame
6 Months, post-operative
Title
Range of Motion
Description
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Time Frame
12 Months, post-operative
Title
Range of Motion
Description
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Time Frame
24 Months, post-oeprative
Title
Isometric Strength
Description
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Time Frame
Baseline, pre-operative
Title
Isometric Strength
Description
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Time Frame
3 Months, post-operative
Title
Isometric Strength
Description
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Time Frame
6 Months, post-operative
Title
Isometric Strength
Description
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Time Frame
12 Months, post-operative
Title
Isometric Strength
Description
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Time Frame
24 Months, post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
70 years of age or older
clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear >2cm or more than 1 full tendon
ongoing symptoms after 3 months of physiotherapy
a tendon amenable to partial or complete repair (as determined by pre-operative MRI)
absence glenohumeral arthritis (Hamada < 3)
absence of neoplastic diseases at treated site
Exclusion Criteria:
previous surgery or pseudoparalysis on study shoulder
complete subscapularis deficiency
external rotation lag signs
avascular necrosis
post-infectious arthritis
proximal humerus fracture
inflammatory arithritis
axillary nerve palsy
concomitant tendon transfer
neuromuscular disorder
unable to speak/read English
Intra-operative Exclusion:
-tendon is NOT amenable to partial or complete repair
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila McRae, PhD
Phone
204-925-7469
Email
smcrae@panamclinic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Brenna Cyr, BKin
Phone
204-927-2828
Email
bcyr@panamclinic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarret Woodmass, MD
Organizational Affiliation
Pan Am Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
RC Repair Versus Subacromial Balloon Spacer in Older Adults
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