RC Repair Versus Subacromial Balloon Spacer in Older Adults

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05788250
• Other study ID #: RCBAL-01-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: October 2027

Study information

• Verified date: April 2024
• Source: Panam Clinic
• Contact: Sheila McRae, PhD
• Phone: 204-925-7469
• Email: smcrae[@]panamclinic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: October 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Subacromial spacer implantation
A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.
• Rotator cuff repair
Rotator cuff repair with tenotomy of long head of biceps.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Panam Clinic	University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study feasibility - randomized	Percentage of patients randomized	1 year
Primary	Study feasibility - recruitment	Number of screened patients and proportion that are deemed eligible that consent	1 year
Primary	Study feasibility - surgery	Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Isometric Strength	Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.	Baseline, pre-operative
Secondary	Isometric Strength	Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.	3 Months, post-operative
Secondary	Isometric Strength	Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.	6 Months, post-operative
Secondary	Isometric Strength	Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.	12 Months, post-operative
Secondary	Isometric Strength	Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.	24 Months, post-operative