RC Repair Versus Subacromial Balloon Spacer in Older Adults

Study Overview
=================
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).

Official Title
-----------------
Randomized Clinical Trial Comparing Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation

Conditions
-----------------
Rotator Cuff Tears

Intervention / Treatment
-----------------
* Procedure: Subacromial spacer implantation
* Procedure: Rotator cuff repair


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subacromial spacer implantation<br> | Procedure: Subacromial spacer implantation<br>* A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.<br>|
| Active Comparator: Rotator Cuff Repair<br> | Procedure: Rotator cuff repair<br>* Rotator cuff repair with tenotomy of long head of biceps.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study feasibility - randomized | Percentage of patients randomized | 1 year | 
| Study feasibility - recruitment | Number of screened patients and proportion that are deemed eligible that consent | 1 year | 
| Study feasibility - surgery | Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, pre-operative | 
| 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 | 3 Months, post-operative | 
| 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 | 6 Months, post-operative | 
| 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 | 12 Months, post-operative | 
| 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 | 24 Months, post-operative | 
| 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. | Baseline, pre-operative | 
| 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. | 3 Months, post-operative | 
| 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. | 6 Months, post-operative | 
| 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. | 12 Months, post-operative | 
| 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. | 24 Months, post-operative | 
| 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)? | Baseline, pre-operative | 
| 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)? | 3 Months, post-operative | 
| 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)? | 6 Months, post-operative | 
| 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)? | 12 Months, post-operative | 
| 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)? | 24 Months, post-operative | 
| 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. | Baseline, pre-operative | 
| 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. | 3 Months, post-operative | 
| 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. | 6 Months, post-operative | 
| 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. | 12 Months, post-operative | 
| 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. | 24 Months, post-operative | 
| 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. | Baseline, pre-operative | 
| 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. | 3 Months, post-oeprative | 
| 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. | 6 Months, post-operative | 
| 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. | 12 Months, post-operative | 
| 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. | 24 Months, post-oeprative | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation. | Baseline, pre-operative | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation. | 3 Months, post-operative | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation. | 6 Months, post-operative | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation. | 12 Months, post-operative | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation. | 24 Months, post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rotator cuff repair, subacromial spacer, older adults