RC Repair Versus Subacromial Balloon Spacer in Older Adults

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

The purpose of this pilot study is to assess the feasibility of a full randomized trial design.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: Subacromial spacer implantation; Procedure: Rotator cuff repair

Detailed Description

The feasibility objectives are:

1. Recruitment

   1. To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent.
   2. To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears.
2. 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:

1. Patient reported and clinical outcomes.
2. Number of "failures" in each group (defined as additional surgery and/or having <12% improvement in SANE score from baseline).

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brenna Cyr, BKin; Phone Number: 204-927-2828; Email: bcyr@panamclinic.com
• Study Contact Backup: Name: Sheila McRae, PhD; Phone Number: 204-925-7469; Email: smcrae@panamclinic.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: Panam Clinic
• Collaborators: University of Manitoba
• Investigators: Principal Investigator: Jarret Woodmass, MD, Pan Am Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: older adults; rotator cuff repair; subacromial spacer
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: RCBAL-01-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No