Full Thickness Rotator Cuff TearNCT01256242
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
A study testing Augment Rotator Cuff and Standard Suture Repair in people with Full Thickness Rotator Cuff Tear, run by BioMimetic Therapeutics at 4 sites in Canada.
Trial summary
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Full Thickness Rotator Cuff Tear
- What is being tested?
- Augment Rotator Cuff and Standard Suture Repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesCanada
- Study dates
- 24 Nov 2010to 16 Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has a repairable rotator cuff tear with an estimated full thickness size of ≥ 2 cm to < 5 cm confirmed with diagnostic MRI in AP or ML dimension
- The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
- The subject is at least twenty one (21) years of age and considered to be skeletally mature.
Who cannot join
- The subject has undergone previous rotator cuff repair surgery to the affected shoulder
- The subject has a partial thickness rotator cuff tear
- The subject requires a concomitant subscapularis repair
- The subject requires a concomitant labral repair
- The subject has an irreparable rotator cuff tear
- The subject has an allergy to yeast-derived products or a known bovine collagen allergy
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- The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder
- The subject has tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed Augment Rotator Cuff implantation site
- The subject's condition represents a worker's compensation case
- The subject is currently involved in a health-related litigation procedure
- The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Fowler Kennedy Sports Medicine Clinic
London, Ontario, N6A 3K7
Hand and Upper Limb Clinic - St. Joseph's Health Care London
London, Ontario, N6A 4L6
Ottawa Hospital
Ottawa, Ontario
St. Michaels Hospital
Toronto, Ontario
About this study
Official title: A Single Blinded, Multi-center, Randomized, Controlled, Pilot Study to Evaluate the Safety and Performance of Augment™ Rotator Cuff for Primary Surgical Treatment of Full Thickness Rotator Cuff Tears
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient.
Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.
- Conditions
- Full Thickness Rotator Cuff Tear
- Being tested
- Augment Rotator Cuff, Standard Suture Repair
- Keywords
- tendon, shoulder, rotator cuff, Glenohumeral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augment Rotator CuffDevice
rhPDGF-BB and bovine collagen matrix
Standard Suture RepairProcedure or surgery
standard suture repair
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Standard Suture Repair + Augment Rotator Cuff Receives: Device: Augment Rotator Cuff |
| Group 2 | Active comparator | Standard Suture Repair Receives: Procedure: Standard Suture Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI)
The scans were evaluated for degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist to assess device integrity and surgical treatment of the rotator cuff tear.
Measured: 24 weeks
Disabilities of the Arm, Shoulder and Hand (DASH)
a self-report questionnaire evaluates the subjects' symptoms and ability to perform activities of daily living, athletic activities and homemaking/work activities. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100
Measured: 24 weeks
Western Ontario Rotator Cuff Index (WORC)
a self-report questionnaire specifically designed to evaluate disability in persons with pathology of the rotator cuff. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100, with a higher score representing lower quality of life.
Measured: 24 weeks
Constant-Murley Shoulder Outcome Score (CSS)
to assess the shoulder and determine at minimum the range of motion (ROM), external rotation and internal rotation, and power score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study start24 Nov 2010
- Primary completion16 Nov 2012
- Study completion16 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Thickness Rotator Cuff TearStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMimetic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Litchfield, MD, FRCSC, Principal investigator, Fowler Kennedy Sport Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256242
- Sponsor's protocol ID
- BMTI-2010-03
- Status last verified
- Feb 2019
- First submitted
- 7 Dec 2010
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blinded, Multi-center, Randomized, Controlled, Pilot Study to Evaluate the Safety and Performance of Augment™ Rotator Cuff for Primary Surgical Treatment of Full Thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT01256242
- Acronym / sponsor ID
- BMTI-2010-03
- Conditions
- Full Thickness Rotator Cuff Tear
- Keywords
- tendon, shoulder, rotator cuff, Glenohumeral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BioMimetic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2010 (actual)
- Primary completion
- 16 Nov 2012 (actual)
- Study completion
- 16 Nov 2012 (actual)
- First posted
- 8 Dec 2010 (estimated)
- 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.
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient.
Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Augment Rotator CuffStandard Suture Repair + Augment Rotator Cuff |
| Group 2 | Active comparator | Procedure: Standard Suture RepairStandard Suture Repair |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject has a repairable rotator cuff tear with an estimated full thickness size of ≥ 2 cm to < 5 cm confirmed with diagnostic MRI in AP or ML dimension
- The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
- The subject is at least twenty one (21) years of age and considered to be skeletally mature.
Key exclusion criteria (11 listed)
- The subject has undergone previous rotator cuff repair surgery to the affected shoulder
- The subject has a partial thickness rotator cuff tear
- The subject requires a concomitant subscapularis repair
- The subject requires a concomitant labral repair
- The subject has an irreparable rotator cuff tear
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 |
|---|---|---|
| Augment Rotator CuffrhPDGF-BB and bovine collagen matrix | Device | Group 1 |
| Standard Suture Repairstandard suture repair | Procedure or surgery | Group 2 |
Primary outcome
Magnetic Resonance Imaging (MRI)
Time frame: 24 weeks
The scans were evaluated for degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist to assess device integrity and surgical treatment of the rotator cuff tear.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 24 weeks
a self-report questionnaire evaluates the subjects' symptoms and ability to perform activities of daily living, athletic activities and homemaking/work activities. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100
Western Ontario Rotator Cuff Index (WORC)
Time frame: 24 weeks
a self-report questionnaire specifically designed to evaluate disability in persons with pathology of the rotator cuff. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100, with a higher score representing lower quality of life.
Constant-Murley Shoulder Outcome Score (CSS)
Time frame: 24 weeks
to assess the shoulder and determine at minimum the range of motion (ROM), external rotation and internal rotation, and power score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- American Academy of Orthopaedic SurgeonsLink provided by the sponsor.
Related trials for Full Thickness Rotator Cuff Tear
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Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
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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. This study is not recruiting at the moment.
Robert Litchfield, MD, FRCSC principal investigator
Fowler Kennedy Sport Medicine Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augment Rotator Cuff and Standard Suture Repair in people with Full Thickness Rotator Cuff Tear, run by BioMimetic Therapeutics at 4 sites 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (MRI) (time frame: 24 weeks). The study lists 4 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 19 Feb 2019.