Rotator Cuff TearsNCT04673344
Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair
A study testing Regeneten Collagen Patch in people with Rotator Cuff Tears and Shoulder Surgery, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Shoulder pain is a common complaint with the most common reason being tendinopathy and/or tearing of the rotator cuff. While many rotator cuff tears are often considered normal, age-related degenerative disorders, with either partial- or full-thickness rotator cuff tears evident in 4% of patients aged <40 years and in… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears, Shoulder Surgery
- What is being tested?
- Regeneten Collagen Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2020to 31 Dec 2021
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 40-75 years with a partial-thickness rotator cuff tear (50% or more) confirmed on MRI scan that, in combination with patient-report symptoms and clinical examination by the orthopaedic surgeon, would confirm the rotator cuff tear as the primary pathology driving pain, symptoms and functional disability .
- Symptoms > 3 months
- Unsuccessful conservative treatment comprising of a corticosteroid injection (into the subacromial bursa) and physiotherapy (while it is acknowledged that a range of modalities may be available to patient's presenting with apparent symptomatic rotator cuff pathology, for the current study, physiotherapy has been defined specifically as a course of 'exercise-based' therapy specific to the individual patient, though generally comprising of exercises designed to strengthen the rotator cuff and scapula stabilizing musculature, improving flexibility and shoulder mobility)
Who cannot join
- Revision surgery
- Cervical pathology
- Adhesive capsulitis
- Multi-tendon tears
- Concomitant upper limb pathology (eg: arthritis, nerve compression)
- Infection
Show all 14Show fewer
- Previous fracture
- Instability
- Pregnancy and lactation
- Professional athlete
- Worker's compensation or compensable claim
- Substance abuse or current mental illness
- Smoker
- Adverse reaction to bovine derived products
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Collagen Scaffold Augmentation of High Grade Partial Rotator Cuff Tendon Tears Improves Early Functional Recovery: A Randomized Controlled Trial.
Shoulder pain is a common complaint with the most common reason being tendinopathy and/or tearing of the rotator cuff. While many rotator cuff tears are often considered normal, age-related degenerative disorders, with either partial- or full-thickness rotator cuff tears evident in 4% of patients aged <40 years and in 54% of patients aged >60 years, once they become symptomatic and conservative management fails, they are typically repaired surgically. Data suggest that the incidence of surgery to repair and re-attach the cuff continues to rise. However, despite positive clinical results overall, reports of repair failure after surgery can range from 16%-94%, and of those that do fail, or fail to heal, generally do so within the first 3 to 6 months post-surgery.
Given the aforementioned reported issues with the gold standard for the treatment of unresponsive and symptomatic partial or full rotator cuff tears (surgical repair), together with the invasiveness of this surgery and lengthy period of restricted activity, other means of treatment have been proposed.
The REGENETEN scaffold/implant seeks to support new tendon growth and disrupt disease progression. This study seeks to investigate the outcome of surgical rotator cuff repair versus scaffold augmentation (using the REGENETEN scaffold) for symptomatic partial thickness rotator cuff tears.
- Conditions
- Rotator Cuff Tears, Shoulder Surgery
- Being tested
- Regeneten Collagen Patch
- 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.
Regeneten Collagen PatchDevice
Partial rotator cuff repair surgery with the addition of the Regeneten scaffold
| Study group | Role | What they receive |
|---|---|---|
| Partial Rotator Cuff Repair | No intervention | Routine partial rotator cuff repair |
| Partial Rotator Cuff Repair with Regeneten Scaffold | Active comparator | Routine partial rotator cuff repair with the addition of the Regeneten scaffolding patch Receives: Device: Regeneten Collagen Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator Cuff Healing
The status of rotator cuff healing as demonstrated on post-operative MRI (at 6, 12 and 24 months)
Measured: 24 months
Participant Satisfaction: ASES assessment
Participant Satisfaction with their surgical outcomes will be measured with the use of the American Shoulder and Elbow Surgeons at 6 week, 3-, 6-, 12- and 24 months after surgery
Measured: 24 months
Participant Satisfaction: WORC assessment
Participant Satisfaction with their surgical outcomes will be measured with the use of the Western Ontario Rotator Cuff Index at 6 week, 3-, 6-, 12- and 24 months after surgery
Measured: 24 months
Participant Satisfaction: SANE assessment
Participant Satisfaction with their surgical outcomes will be measured with the use of the Single Assessment Numeric Evaluation at 6 week, 3-, 6-, 12- and 24 months after surgery
Measured: 24 months
Participant Satisfaction: VR-12 assessment
Participant Satisfaction with their surgical outcomes will be measured with the use of the Veteran's Rand 12 assessment at 6 week, 3-, 6-, 12- and 24 months after surgery
Measured: 24 months
Participant Satisfaction: GRC assessment
Participant Satisfaction with their surgical outcomes will be measured with the use of the Global Rating of Change scale at 6 week, 3-, 6-, 12- and 24 months after surgery
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start30 Dec 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673344
- Sponsor's protocol ID
- FTJO2020-0876
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Scaffold Augmentation of High Grade Partial Rotator Cuff Tendon Tears Improves Early Functional Recovery: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04673344
- Acronym / sponsor ID
- FTJO2020-0876
- Conditions
- Rotator Cuff Tears, Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 30 Dec 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Dec 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.
Shoulder pain is a common complaint with the most common reason being tendinopathy and/or tearing of the rotator cuff. While many rotator cuff tears are often considered normal, age-related degenerative disorders, with either partial- or full-thickness rotator cuff tears evident in 4% of patients aged <40 years and in 54% of patients aged >60 years, once they become symptomatic and conservative management fails, they are typically repaired surgically. Data suggest that the incidence of surgery to repair and re-attach the cuff continues to rise. However, despite positive clinical results overall, reports of repair failure after surgery can range from 16%-94%, and of those that do fail, or fail to heal, generally do so within the first 3 to 6 months post-surgery.
Given the aforementioned reported issues with the gold standard for the treatment of unresponsive and symptomatic partial or full rotator cuff tears (surgical repair), together with the invasiveness of this surgery and lengthy period of restricted activity, other means of treatment have been proposed.
The REGENETEN scaffold/implant seeks to support new tendon growth and disrupt disease progression. This study seeks to investigate the outcome of surgical rotator cuff repair versus scaffold augmentation (using the REGENETEN scaffold) for symptomatic partial thickness rotator cuff tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Rotator Cuff Repair | No intervention | –Routine partial rotator cuff repair |
| Partial Rotator Cuff Repair with Regeneten Scaffold | Active comparator | Device: Regeneten Collagen PatchRoutine partial rotator cuff repair with the addition of the Regeneten scaffolding patch |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females aged 40-75 years with a partial-thickness rotator cuff tear (50% or more) confirmed on MRI scan that, in combination with patient-report symptoms and clinical examination by the orthopaedic surgeon, would confirm the rotator cuff tear as the primary pathology driving pain, symptoms and functional disability .
- Symptoms > 3 months
- Unsuccessful conservative treatment comprising of a corticosteroid injection (into the subacromial bursa) and physiotherapy (while it is acknowledged that a range of modalities may be available to patient's presenting with apparent symptomatic rotator cuff pathology, for the current study, physiotherapy has been defined specifically as a course of 'exercise-based' therapy specific to the individual patient, though generally comprising of exercises designed to strengthen the rotator cuff and scapula stabilizing musculature, improving flexibility and shoulder mobility)
Key exclusion criteria (14 listed)
- Revision surgery
- Cervical pathology
- Adhesive capsulitis
- Multi-tendon tears
- Concomitant upper limb pathology (eg: arthritis, nerve compression)
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 |
|---|---|---|
| Regeneten Collagen PatchPartial rotator cuff repair surgery with the addition of the Regeneten scaffold | Device | Partial Rotator Cuff Repair with Regeneten Scaffold |
Primary outcome
Rotator Cuff Healing
Time frame: 24 months
The status of rotator cuff healing as demonstrated on post-operative MRI (at 6, 12 and 24 months)
Participant Satisfaction: ASES assessment
Time frame: 24 months
Participant Satisfaction with their surgical outcomes will be measured with the use of the American Shoulder and Elbow Surgeons at 6 week, 3-, 6-, 12- and 24 months after surgery
Participant Satisfaction: WORC assessment
Time frame: 24 months
Participant Satisfaction with their surgical outcomes will be measured with the use of the Western Ontario Rotator Cuff Index at 6 week, 3-, 6-, 12- and 24 months after surgery
Participant Satisfaction: SANE assessment
Time frame: 24 months
Participant Satisfaction with their surgical outcomes will be measured with the use of the Single Assessment Numeric Evaluation at 6 week, 3-, 6-, 12- and 24 months after surgery
Participant Satisfaction: VR-12 assessment
Time frame: 24 months
Participant Satisfaction with their surgical outcomes will be measured with the use of the Veteran's Rand 12 assessment at 6 week, 3-, 6-, 12- and 24 months after surgery
Participant Satisfaction: GRC assessment
Time frame: 24 months
Participant Satisfaction with their surgical outcomes will be measured with the use of the Global Rating of Change scale at 6 week, 3-, 6-, 12- and 24 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Collagen Patch in people with Rotator Cuff Tears and Shoulder Surgery, run by Rothman Institute Orthopaedics at 1 site in United States.
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 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 17 Dec 2020. 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 United States. 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?
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?
Rotator Cuff Healing (time frame: 24 months). The study lists 6 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 17 Dec 2020.