RC Repair Versus Subacromial Balloon Spacer in Older Adults
Study Details
Study Description
Brief Summary
The purpose of this pilot study is to assess the feasibility of a full randomized trial design.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subacromial spacer implantation
|
Procedure: Subacromial spacer implantation
A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.
|
| Active Comparator: Rotator Cuff Repair
|
Procedure: Rotator cuff repair
Rotator cuff repair with tenotomy of long head of biceps.
|
Outcome Measures
Primary Outcome Measures
- Study feasibility - randomized [1 year]
Percentage of patients randomized
- Study feasibility - recruitment [1 year]
Number of screened patients and proportion that are deemed eligible that consent
- Study feasibility - surgery [1 year]
Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.
Secondary Outcome Measures
- ASES Score [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.
- ASES Score [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
- ASES Score [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
- ASES Score [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
- ASES Score [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
- EQ5D-3L [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.
- EQ5D-3L [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.
- EQ5D-3L [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.
- EQ5D-3L [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.
- EQ5D-3L [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.
- SANE Score [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)?"
- SANE Score [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)?"
- SANE Score [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)?"
- SANE Score [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)?"
- SANE Score [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)?"
- Constant Score [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.
- Constant Score [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.
- Constant Score [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.
- Constant Score [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.
- Constant Score [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.
- Range of Motion [Baseline, pre-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.
- Range of Motion [3 Months, post-oeprative]
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 [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.
- Range of Motion [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.
- Range of Motion [24 Months, post-oeprative]
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 [Baseline, pre-operative]
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
- Isometric Strength [3 Months, post-operative]
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
- Isometric Strength [6 Months, post-operative]
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
- Isometric Strength [12 Months, post-operative]
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
- Isometric Strength [24 Months, post-operative]
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Panam Clinic
- University of Manitoba
Investigators
- Principal Investigator: Jarret Woodmass, MD, Pan Am Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RCBAL-01-2023