Rotator Cuff TearsNCT05788250
RC Repair Versus Subacromial Balloon Spacer in Older Adults
A study testing Subacromial spacer implantation and Rotator cuff repair in people with Rotator Cuff Tears, run by Panam Clinic.
Trial summary
The purpose of this pilot study is to assess the feasibility of a full randomized trial design. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Subacromial spacer implantation and Rotator cuff repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- previous surgery or pseudoparalysis on study shoulder
- complete subscapularis deficiency
- external rotation lag signs
- avascular necrosis
- post-infectious arthritis
- proximal humerus fracture
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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).
- Conditions
- Rotator Cuff Tears
- Being tested
- Subacromial spacer implantation, Rotator cuff repair
- Keywords
- rotator cuff repair, subacromial spacer, older adults
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subacromial spacer implantationProcedure or surgery
A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.
Rotator cuff repairProcedure or surgery
Rotator cuff repair with tenotomy of long head of biceps.
| Study group | Role | What they receive |
|---|---|---|
| Subacromial spacer implantation | Experimental | Not described Receives: Procedure: Subacromial spacer implantation |
| Rotator Cuff Repair | Active comparator | Not described Receives: Procedure: Rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility - randomized
Percentage of patients randomized
Measured: 1 year
Study feasibility - recruitment
Number of screened patients and proportion that are deemed eligible that consent
Measured: 1 year
Study feasibility - surgery
Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.
Measured: 1 year
Secondary outcomes (30)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)?"
Measured: 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)?"
Measured: 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)?"
Measured: 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)?"
Measured: 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)?"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 Months, post-oeprative
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Measured: Baseline, pre-operative
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Measured: 3 Months, post-operative
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Measured: 6 Months, post-operative
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Measured: 12 Months, post-operative
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation.
Measured: 24 Months, post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study startAug 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Sponsor
- Investigators
- Jarret Woodmass, MD, Principal investigator, Pan Am Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788250
- Sponsor's protocol ID
- RCBAL-01-2023
- Status last verified
- Apr 2024
- First submitted
- 1 Feb 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation
- ClinicalTrials.gov ID
- NCT05788250
- Acronym / sponsor ID
- RCBAL-01-2023
- Conditions
- Rotator Cuff Tears
- Keywords
- rotator cuff repair, subacromial spacer, older adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- Aug 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subacromial spacer implantation | Experimental | Procedure: Subacromial spacer implantation |
| Rotator Cuff Repair | Active comparator | Procedure: Rotator cuff repair |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- previous surgery or pseudoparalysis on study shoulder
- complete subscapularis deficiency
- external rotation lag signs
- avascular necrosis
- post-infectious arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subacromial spacer implantationA biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps. | Procedure or surgery | Subacromial spacer implantation |
| Rotator cuff repairRotator cuff repair with tenotomy of long head of biceps. | Procedure or surgery | Rotator Cuff Repair |
Primary outcome
Study feasibility - randomized
Time frame: 1 year
Percentage of patients randomized
Study feasibility - recruitment
Time frame: 1 year
Number of screened patients and proportion that are deemed eligible that consent
Study feasibility - surgery
Time frame: 1 year
Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.
30 secondary outcomes
ASES Score
Time frame: Baseline, pre-operative
ASES Score
Time frame: 3 Months, post-operative
ASES Score
Time frame: 6 Months, post-operative
ASES Score
Time frame: 12 Months, post-operative
ASES Score
Time frame: 24 Months, post-operative
EQ5D-3L
Time frame: Baseline, pre-operative
EQ5D-3L
Time frame: 3 Months, post-operative
EQ5D-3L
Time frame: 6 Months, post-operative
EQ5D-3L
Time frame: 12 Months, post-operative
EQ5D-3L
Time frame: 24 Months, post-operative
SANE Score
Time frame: Baseline, pre-operative
SANE Score
Time frame: 3 Months, post-operative
SANE Score
Time frame: 6 Months, post-operative
SANE Score
Time frame: 12 Months, post-operative
SANE Score
Time frame: 24 Months, post-operative
Constant Score
Time frame: Baseline, pre-operative
Constant Score
Time frame: 3 Months, post-operative
Constant Score
Time frame: 6 Months, post-operative
Constant Score
Time frame: 12 Months, post-operative
Constant Score
Time frame: 24 Months, post-operative
Range of Motion
Time frame: Baseline, pre-operative
Range of Motion
Time frame: 3 Months, post-oeprative
Range of Motion
Time frame: 6 Months, post-operative
Range of Motion
Time frame: 12 Months, post-operative
Range of Motion
Time frame: 24 Months, post-oeprative
Isometric Strength
Time frame: Baseline, pre-operative
Isometric Strength
Time frame: 3 Months, post-operative
Isometric Strength
Time frame: 6 Months, post-operative
Isometric Strength
Time frame: 12 Months, post-operative
Isometric Strength
Time frame: 24 Months, post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jarret Woodmass, MD principal investigator
Pan Am Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Subacromial spacer implantation and Rotator cuff repair in people with Rotator Cuff Tears, run by Panam Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheila McRae, PhD (204-925-7469, smcrae@panamclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility - randomized (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.