Rotator Cuff TearNCT04248751
Evaluating the Use of a Bioinductive Graft in Treating Massive Rotator Cuff Tears
A study testing Regeneten and Debridement in people with Rotator Cuff Tear and Rotator Cuff Injury, run by Ivan Wong at 1 site in Canada.
Trial summary
The rotator cuff is a complex of 4 tendons that aid in stabilizing and moving the shoulder. Rotator cuff tears are common shoulder injuries in adults. While some tears can be managed by physiotherapy, other rotator cuff tears will require surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear, Rotator Cuff Injury
- What is being tested?
- Regeneten and Debridement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2021to Aug 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Magnetic resonance imaging (MRI) proven diagnosis of a large >3cm tear of the shoulder rotator cuff in a competent adult (>18 years of age).
Who cannot join
- Patients with subscapular tear
- Glenohumeral osteoarthritis
- A normalized WORC score >70 (where scores range between 0-100, and 100 is the best outcome)
- Uncontrolled diabetes (Hgb A1C >7%)
- Pregnancy
- Presence of local or systemic infection
Show all 14Show fewer
- Inability to cooperate with and/or comprehend post-operative instructions
- Nonvascular surgical sites (MRI proven)
- Poor nutritional state (Alb <30 g/L)
- Cancer
- Paralysis of the shoulder
- Contracture of the shoulder
- Presence of cuff tear arthropathy or osteoarthritis of the shoulder
- Patients unable to provide informed consent for the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2E1
Sara Sparavalo, MASc, 9024737626, research@drivanwong.com
Ivan H Wong, MD
About this study
Official title: A Prospective, Randomized Evaluation of Bioinductive Augmentation for High Risk Rotator Cuff Tears
The rotator cuff is a complex of 4 tendons that aid in stabilizing and moving the shoulder. Rotator cuff tears are common shoulder injuries in adults. While some tears can be managed by physiotherapy, other rotator cuff tears will require surgery. On occasion, when a person has had a large rotator cuff tear for a long period of time, the tear can grow and the tendons retract. This effect makes it very difficult for the tendons to be repaired to their normal spot.
The most common surgical technique employed to manage a tear that cannot be repaired is to remove all unhealthy, inflamed scar tissue in a process called debridement. Often there is a bone spur that must be shaved down as well. This can help to reduce the pain in the patient as well as assist the range of motion slightly but will not prevent the tear becoming larger. This will also not prevent a re-tear of the tendons.
Read more
Recently, surgeons have begun using a variety of materials to help reconstruct torn rotator cuffs. New grafts made of highly purified collagen from bovine tendons has been used to bridge large gaps in the tendons, and repair the tendon back to the bone. This technique has been done many times by skilled shoulder surgeons in Canada, the United States and around the world.
Initial reports by surgeons who do this procedure show that the patients have less pain and better range of motion than before the surgery. Shoulder surgeons do not know which is the better treatment for large rotator cuff tears. Both treatments (graft and debridement) can reduce pain and improve movement of the shoulder. The purpose of this study is to help determine whether patients who receive an allograft have better function and fewer re-tear at one year after surgery than those who received a debridement alone.
Read the detailed description
Rotator cuff injuries are among the most common soft tissue injuries of the shoulder. Characterized by insidious onset of progressive pain and weakness, with concomitant loss of range of motion, patients with pathological conditions of the rotator cuff are often unable to associate the onset of symptoms with a specific traumatic event. Loss of continuity of the rotator cuff can be described in several ways, including acute or chronic, partial or full-thickness and traumatic or degenerative. For this study, only patients with radiography confirmed large rotator cuff tears (> 3 cm) resulting from trauma and/or degeneration will be observed.
Historically, many operative procedures have been used by surgeons in the treatment of large rotator cuff tears including open rotator cuff repair, mini- open rotator cuff repair, arthroscopic rotator cuff repair, bridging techniques, debridement, arthroscopic rotator cuff repair with acromioplasty, arthroscopic rotator cuff repair without acromioplasty, surgical augmentation, debridement etc. While the surgical repair of large rotator cuff tears has resulted in pain relief and improved function, the re-tear rate (55%-94%) has remained high despite advances in repair techniques. The re-tear rates correlate with the size of the rotator cuff tear as well as with other factors such as muscle atrophy, tendon quality, and postoperative rehabilitation protocol.
With an effort to improve healing rates, surgeons have used various biologic tissues to either substitute for or augment the repair of the rotator cuff. These tissues include the patients' biceps tendon, fascia latae allografts and autografts, freeze-dried rotator cuff allografts, and synthetic materials such as polypropylene mesh.1 A new scaffold material made of highly purified, type I collagen from bovine tendons has shown great promise as a bioinductive implant that helps induce the formation of new tendon-like tissue over the surface of partial- or full-thickness rotator cuff tears.This new graft material has the benefit of decreasing surgery time, as it takes a few minutes to put in place, while increasing healing and tendon thickness.
The investigators hypothesize that arthroscopic augmentation using a bioinductive collagen implant will have superior outcomes in terms of increasing healing, thereby decreasing re-tear rate, as compared to participants who are treated with the current gold standard treatment (consisting of debridement, acromioplasty, and rotator cuff repair). The investigators hypothesize that the participants with graft augment will have decreased pain both during the early recovery phase and two years post-operatively as compared to the non-augmented group. Additionally, the investigators hypothesize that participants with the collagen scaffold will have better outcome scores at two years, as compared to the non-augmented group.
- Conditions
- Rotator Cuff Tear, Rotator Cuff Injury
- Being tested
- Regeneten, Debridement
- 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.
RegenetenDevice
A new scaffold material made of highly purified, type I collagen from bovine tendons has shown great promise as a bioinductive implant that helps induce the formation of new tendon-like tissue over the surface of partial- or full-thickness rotator cuff tears. This new graft material has the benefit of decreasing surgery time, as it takes a few minutes to put in place, while increasing healing and tendon thickness.
DebridementProcedure or surgery
The bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin
| Study group | Role | What they receive |
|---|---|---|
| Graft-Augmented | Experimental | Patients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin. Then, the graft will be delivered to the subacromial space and positioned over the bursal surface of the suprasinatus tendon, ensuring that the lateral edge of the implant will overlap with the head of the humerus. The graft will be fixed with tendon and bone staples. Receives: Device: Regeneten |
| Non-augmented | Active comparator | Patients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin. Receives: Procedure: Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
A change in healing to be assessed by comparing re-tear rates.
Measured: 2 years
Secondary outcomes (7)
VAS Pain
Pain will be assessed using the Visual Analogue Scale (VAS) pain scale, a scale from 1 to 10 where 10 represents the best health and 1 represents worse health.
Measured: Early recovery phase and 2 years
Western Ontario Rotator Cuff Index
A questionnaire used to determine shoulder function in patients with rotator cuff tears
Measured: 1 and 2 years
Marx Shoulder Activity Scale
Activity survey that is short, easy to administer and is a good measure of shoulder activity which could be used to predict outcome of shoulder disorders
Measured: 1 and 2 years
Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.
Measured: 1 and 2 years
American Shoulder and Elbow Surgeons (ASES) Questionnaire
American Shoulder and Elbow Surgeons (ASES) questionnaire is a validated, self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.
Measured: 1 and 2 years
Veterans Rand 12-Item Health Survey (VR12)
Questionnaire used to assess general health
Measured: 1 and 2 years
EQ5D-5L
Questionnaires used to assess general health that is also commonly used during economic analysis.
Measured: 1 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 posted30 Jan 2020
- Study start1 Jan 2021
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Model description
- Patients that have consented to the study will be randomized into 2 groups with a 50% chance of being in either group. Patients will be blinded and assessed by blinded assessors. Only after the one-year mark will the patient become unblinded following being asked which intervention they believe they received. Crossover design: Among those 38 patients without augmentation, we anticipate that 23 of them will have re-tear (assuming a 60% re-tear rate). We will offer them revision surgery with augmentation. Then those patients will be followed up 1 year and 2-years afterwards. MRI follow-up will be done at 1 year postoperatively to assess the healing rates. Outcome scores (as per above) will be collected at each follow-up and compared with their non-augmented scores to assess the improvement.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ivan Wong
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor-investigator, Ivan Wong, Nova Scotia Health Authority
- Investigators
- Ivan Wong, MD, Principal investigator, Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248751
- Sponsor's protocol ID
- Regen
- Status last verified
- Sep 2023
- First submitted
- 15 Nov 2019
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Evaluation of Bioinductive Augmentation for High Risk Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT04248751
- Acronym / sponsor ID
- Regen
- Conditions
- Rotator Cuff Tear, Rotator Cuff Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Ivan WongUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 30 Jan 2020 (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 rotator cuff is a complex of 4 tendons that aid in stabilizing and moving the shoulder. Rotator cuff tears are common shoulder injuries in adults. While some tears can be managed by physiotherapy, other rotator cuff tears will require surgery. On occasion, when a person has had a large rotator cuff tear for a long period of time, the tear can grow and the tendons retract. This effect makes it very difficult for the tendons to be repaired to their normal spot.
The most common surgical technique employed to manage a tear that cannot be repaired is to remove all unhealthy, inflamed scar tissue in a process called debridement. Often there is a bone spur that must be shaved down as well. This can help to reduce the pain in the patient as well as assist the range of motion slightly but will not prevent the tear becoming larger. This will also not prevent a re-tear of the tendons.
Recently, surgeons have begun using a variety of materials to help reconstruct torn rotator cuffs. New grafts made of highly purified collagen from bovine tendons has been used to bridge large gaps in the tendons, and repair the tendon back to the bone. This technique has been done many times by skilled shoulder surgeons in Canada, the United States and around the world.
Initial reports by surgeons who do this procedure show that the patients have less pain and better range of motion than before the surgery. Shoulder surgeons do not know which is the better treatment for large rotator cuff tears. Both treatments (graft and debridement) can reduce pain and improve movement of the shoulder. The purpose of this study is to help determine whether patients who receive an allograft have better function and fewer re-tear at one year after surgery than those who received a debridement alone.
Detailed description
Rotator cuff injuries are among the most common soft tissue injuries of the shoulder. Characterized by insidious onset of progressive pain and weakness, with concomitant loss of range of motion, patients with pathological conditions of the rotator cuff are often unable to associate the onset of symptoms with a specific traumatic event. Loss of continuity of the rotator cuff can be described in several ways, including acute or chronic, partial or full-thickness and traumatic or degenerative. For this study, only patients with radiography confirmed large rotator cuff tears (> 3 cm) resulting from trauma and/or degeneration will be observed.
Historically, many operative procedures have been used by surgeons in the treatment of large rotator cuff tears including open rotator cuff repair, mini- open rotator cuff repair, arthroscopic rotator cuff repair, bridging techniques, debridement, arthroscopic rotator cuff repair with acromioplasty, arthroscopic rotator cuff repair without acromioplasty, surgical augmentation, debridement etc. While the surgical repair of large rotator cuff tears has resulted in pain relief and improved function, the re-tear rate (55%-94%) has remained high despite advances in repair techniques. The re-tear rates correlate with the size of the rotator cuff tear as well as with other factors such as muscle atrophy, tendon quality, and postoperative rehabilitation protocol.
With an effort to improve healing rates, surgeons have used various biologic tissues to either substitute for or augment the repair of the rotator cuff. These tissues include the patients' biceps tendon, fascia latae allografts and autografts, freeze-dried rotator cuff allografts, and synthetic materials such as polypropylene mesh.1 A new scaffold material made of highly purified, type I collagen from bovine tendons has shown great promise as a bioinductive implant that helps induce the formation of new tendon-like tissue over the surface of partial- or full-thickness rotator cuff tears.This new graft material has the benefit of decreasing surgery time, as it takes a few minutes to put in place, while increasing healing and tendon thickness.
The investigators hypothesize that arthroscopic augmentation using a bioinductive collagen implant will have superior outcomes in terms of increasing healing, thereby decreasing re-tear rate, as compared to participants who are treated with the current gold standard treatment (consisting of debridement, acromioplasty, and rotator cuff repair). The investigators hypothesize that the participants with graft augment will have decreased pain both during the early recovery phase and two years post-operatively as compared to the non-augmented group. Additionally, the investigators hypothesize that participants with the collagen scaffold will have better outcome scores at two years, as compared to the non-augmented group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients that have consented to the study will be randomized into 2 groups with a 50% chance of being in either group. Patients will be blinded and assessed by blinded assessors. Only after the one-year mark will the patient become unblinded following being asked which intervention they believe they received. Crossover design: Among those 38 patients without augmentation, we anticipate that 23 of them will have re-tear (assuming a 60% re-tear rate). We will offer them revision surgery with augmentation. Then those patients will be followed up 1 year and 2-years afterwards. MRI follow-up will be done at 1 year postoperatively to assess the healing rates. Outcome scores (as per above) will be collected at each follow-up and compared with their non-augmented scores to assess the improvement.
| Arm | Type | Receives |
|---|---|---|
| Graft-Augmented | Experimental | Device: RegenetenPatients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin. Then, the graft will be delivered to the subacromial space and positioned over the bursal surface of the suprasinatus tendon, ensuring that the lateral edge of the implant will overlap with the head of the humerus. The graft will be fixed with tendon and bone staples. |
| Non-augmented | Active comparator | Procedure: DebridementPatients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Magnetic resonance imaging (MRI) proven diagnosis of a large >3cm tear of the shoulder rotator cuff in a competent adult (>18 years of age).
Key exclusion criteria (14 listed)
- Patients with subscapular tear
- Glenohumeral osteoarthritis
- A normalized WORC score >70 (where scores range between 0-100, and 100 is the best outcome)
- Uncontrolled diabetes (Hgb A1C >7%)
- Pregnancy
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 |
|---|---|---|
| RegenetenA new scaffold material made of highly purified, type I collagen from bovine tendons has shown great promise as a bioinductive implant that helps induce the formation of new tendon-like tissue over the surface of partial- or full-thickness rotator cuff tears. This new graft material has the benefit of decreasing surgery time, as it takes a few minutes to put in place, while increasing healing and tendon thickness. | Device | Graft-Augmented |
| DebridementThe bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin | Procedure or surgery | Non-augmented |
Primary outcome
Healing
Time frame: 2 years
A change in healing to be assessed by comparing re-tear rates.
7 secondary outcomes
VAS Pain
Time frame: Early recovery phase and 2 years
Western Ontario Rotator Cuff Index
Time frame: 1 and 2 years
Marx Shoulder Activity Scale
Time frame: 1 and 2 years
Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire
Time frame: 1 and 2 years
American Shoulder and Elbow Surgeons (ASES) Questionnaire
Time frame: 1 and 2 years
Veterans Rand 12-Item Health Survey (VR12)
Time frame: 1 and 2 years
EQ5D-5L
Time frame: 1 and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- 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. This study is not recruiting at the moment.
Ivan Wong, MD principal investigator
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 Regeneten and Debridement in people with Rotator Cuff Tear and Rotator Cuff Injury, run by Ivan Wong 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 1 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Sparavalo, MASc (9024734251, sara@drivanwong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (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 6 Sep 2023.