Rotator Cuff TearsNCT05959733
Maximal Repair Versus Bridging Reconstruction with BioBrace®
A study testing Bridging Reconstruction using BioBrace and Repair in people with Rotator Cuff Tears and Bioinductive Implant, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Bioinductive Implant
- What is being tested?
- Bridging Reconstruction using BioBrace and Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 7 Dec 2023to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- magnetic resonance imaging (MRI) proven diagnosis of a large or massive (> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
- over 18 years of age
Who cannot join
- glenohumeral osteoarthritis
- Western Ontario rotator cuff score >60
- uncontrolled diabetes (Hgb A1C >7%)
- pregnant
- local or systemic infection
- inability to cooperate with and/or comprehend post-operative instructions
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- MRI proven non-vascular sites
- poor nutritional state (Alb <30 g/L)
- cancer
- paralysis of the shoulder
- contracture of the shoulder
- patients unable to provide informed consent for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H2E1
Ivan Wong, 9024737626, research@drivanwong.com
About this study
Official title: Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis
The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.
- Conditions
- Rotator Cuff Tears, Bioinductive Implant
- Being tested
- Bridging Reconstruction using BioBrace, Repair
- Keywords
- shoulder, rotator cuff, clinical outcomes, radiographic outcomes, biomechanics, bridging reconstruction, rotator cuff repair
- 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.
Bridging Reconstruction using BioBraceProcedure or surgery
Patients in the reconstruction group will undergo maximal repair with interposition bridging using BioBrace. This technique will follow a previously described technique by the principal investigator with differences allocated to the graft, it's preparation and insertion. The bursa will be debrided, and rotator cuff edged will be shaved down to stable tissue. BioBrace is bioinductive scaffold composed of highly porous type I collagen and bio-resorbable poly (L-lactide) (PLLA) microfilaments, and will be used as the graft in this trial.
RepairProcedure or surgery
Patients in the maximal repair group will undergo a SCOI-row rotator cuff repair with adequate tension as described previously, with recreation of the rotator cable. Briefly, the SCOI-row rotator cuff repair uses one triple loaded suture anchor for each 1.2cm of torn tendon. This technique has been completed in a previous randomized controlled trial.
| Study group | Role | What they receive |
|---|---|---|
| Repair | Active comparator | This group will undergo a rotator cuff repair procedure. Receives: Procedure: Repair |
| Bridging Reconstruction using BioBrace | Experimental | This experimental group will undergo bridging reconstruction using the bioinductive implant, BioBrace. Receives: Procedure: Bridging Reconstruction using BioBrace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic or clinical failure
The primary outcome measure for this study will be radiographic and/or clinical failure defined as a rotator cuff tear of equal or larger size than at baseline or does not meet WORC score MCID compared to baseline at any follow up
Measured: 2 years
Secondary outcomes (10)
Acromiohumeral Distance
Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays.
Measured: 2 year
Muscle Atrophy
Using MRI, muscle atrophy will be measured using Warner's classification between groups.
Measured: 2 year
Fatty Infiltration
Fatty infiltration using the Goutallier classification will be used and identified
Measured: 2 year
Healing Rate
To measure the structural integrity of the surgery, Sugaya method will be used.
Measured: 2 year
Western Ontario Rotator Cuff Index (WORC)
WORC will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
Measured: Baseline, 6-month, 1-year, 2-years
American Shoulder and Elbow Surgeon survey
American Shoulder and Elbow Surgeon survey will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
Measured: Baseline, 6-month, 1-year, 2-years
EQ-5D-5L
EQ-5D-5L for overall health will be measured pre-operatively, and post-operatively at 6-months, 1-year, and 2-years
Measured: Baseline, 6-month, 1-year, 2-years
Range of motion
The range of motion, measured in degrees for flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
Measured: Baseline, 6-month, 1-year, 2-years
Shoulder strength
The strength of patients flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
Measured: Baseline, 6-month, 1-year, 2-years
Biomechanics and Muscle Activity
Pre- and post-operative (1-year) in-vivo biomechanics and electromyography will be compared between groups during a standardized shoulder lifting study in a laboratory based environment.
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start7 Dec 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 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.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- CONMED Corporation
- Responsible party
- Principal investigator, Ivan Wong, MD, Nova Scotia Health Authority
- Investigators
- Ivan Wong, MD, Principal investigator, Nova Scotia Health Authority, Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959733
- Sponsor's protocol ID
- BioBridge
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis
- ClinicalTrials.gov ID
- NCT05959733
- Acronym / sponsor ID
- BioBridge
- Conditions
- Rotator Cuff Tears, Bioinductive Implant
- Keywords
- shoulder, rotator cuff, clinical outcomes, radiographic outcomes, biomechanics, bridging reconstruction, rotator cuff repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- CONMED Corporation
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Jul 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 study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repair | Active comparator | Procedure: RepairThis group will undergo a rotator cuff repair procedure. |
| Bridging Reconstruction using BioBrace | Experimental | Procedure: Bridging Reconstruction using BioBraceThis experimental group will undergo bridging reconstruction using the bioinductive implant, BioBrace. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- magnetic resonance imaging (MRI) proven diagnosis of a large or massive (> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
- over 18 years of age
Key exclusion criteria (12 listed)
- glenohumeral osteoarthritis
- Western Ontario rotator cuff score >60
- uncontrolled diabetes (Hgb A1C >7%)
- pregnant
- local or systemic infection
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 |
|---|---|---|
| Bridging Reconstruction using BioBracePatients in the reconstruction group will undergo maximal repair with interposition bridging using BioBrace. This technique will follow a previously described technique by the principal investigator with differences allocated to the graft, it's preparation and insertion. The bursa will be debrided, and rotator cuff edged will be shaved down to stable tissue. BioBrace is bioinductive scaffold composed of highly porous type I collagen and bio-resorbable poly (L-lactide) (PLLA) microfilaments, and will be used as the graft in this trial. | Procedure or surgery | Bridging Reconstruction using BioBrace |
| RepairPatients in the maximal repair group will undergo a SCOI-row rotator cuff repair with adequate tension as described previously, with recreation of the rotator cable. Briefly, the SCOI-row rotator cuff repair uses one triple loaded suture anchor for each 1.2cm of torn tendon. This technique has been completed in a previous randomized controlled trial. | Procedure or surgery | Repair |
Primary outcome
Radiographic or clinical failure
Time frame: 2 years
The primary outcome measure for this study will be radiographic and/or clinical failure defined as a rotator cuff tear of equal or larger size than at baseline or does not meet WORC score MCID compared to baseline at any follow up
10 secondary outcomes
Acromiohumeral Distance
Time frame: 2 year
Muscle Atrophy
Time frame: 2 year
Fatty Infiltration
Time frame: 2 year
Healing Rate
Time frame: 2 year
Western Ontario Rotator Cuff Index (WORC)
Time frame: Baseline, 6-month, 1-year, 2-years
American Shoulder and Elbow Surgeon survey
Time frame: Baseline, 6-month, 1-year, 2-years
EQ-5D-5L
Time frame: Baseline, 6-month, 1-year, 2-years
Range of motion
Time frame: Baseline, 6-month, 1-year, 2-years
Shoulder strength
Time frame: Baseline, 6-month, 1-year, 2-years
Biomechanics and Muscle Activity
Time frame: Baseline and 2 years
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 18 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Ivan Wong, MD principal investigator
Nova Scotia Health Authority, Orthopaedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridging Reconstruction using BioBrace and Repair in people with Rotator Cuff Tears and Bioinductive Implant, run by Nova Scotia Health Authority at 1 site in Canada.
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 2 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Sarah Remedios, MSc (9024737626, research@drivanwong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic or clinical failure (time frame: 2 years). 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 18 Feb 2025.