Rotator Cuff TearsPhase 4NCT05439850
Bioinductive Patch for Full-Thickness Rotator Cuff Tears
A Phase 4 study testing arthroscopic rotator cuff repair, Bioinductive implant and Ultrasound Imaging in people with Rotator Cuff Tears and Rotator Cuff Tear Arthropathy, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
- What is being tested?
- arthroscopic rotator cuff repair, Bioinductive implant and Ultrasound Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 1 Jul 2029
- Phase
- Phase 4
- 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
- Indicated and scheduled for arthroscopic rotator cuff repair.
- Full-thickness medium (1-3 cm), large (3-5 cm), and massive (>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
- Chronic, degenerative rotator cuff tears.
- Ability to read and understand English.
- Age ≥18 years
- Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy
Who cannot join
- Patient scheduled for open or mini-open rotator cuff repair
- Prior surgery of affected shoulder (except diagnostic arthroscopy)
- Partial-thickness rotator cuff tears
- Small (<1 cm) rotator cuff tears
- Rotator cuff tears involving the subscapularis tendon
- Acute and traumatic rotator cuff tears
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- Active infection
- Cancer
- Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stephanie J Muh, MD contact
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Johnny Kasto, MD, 3132448078, jkasto1@hfhs.org
Stephanie J Muh, MD
About this study
Official title: Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.
Read the detailed description
A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non-surgical/conservative options for 6 weeks. Patients in the "control group" will receive the standard surgery (arthroscopic rotator cuff repair) . Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
- Being tested
- arthroscopic rotator cuff repair, Bioinductive implant, Ultrasound Imaging
- Keywords
- Rotator Cuff Tear, Bioinductive, Arthroscopic Rotator Cuff Repair, Rotator Cuff Tear Arthropathy
- Medical subject headings
- Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic rotator cuff repairProcedure or surgery
This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.
Bioinductive implantBiological
Also called Bioinductive patch
A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.
Ultrasound ImagingDiagnostic test
An ultrasound will be performed on each patient one year postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year. Receives: Procedure: arthroscopic rotator cuff repair; Diagnostic Test: Ultrasound Imaging |
| Study Group | Experimental | Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year. Receives: Procedure: arthroscopic rotator cuff repair; Biological: Bioinductive implant; Diagnostic Test: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff repair integrity
absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.
Measured: Preoperative to 1 year postoperative
Secondary outcomes (7)
PROMs scores for upper extremity function
Patient-Reported Outcome Measures (PROMs) scores for upper extremity function. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 0 - 100-point scale, with a score of 50 representing the mean of the population at large, 0 representing the minimum, and 100 representing the maximum function.
Measured: Preoperative to 2 years postoperative
PROMs scores for depression
Patient-Reported Outcome Measures (PROMs) scores for depression. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher increased depression (worse).
Measured: Preoperative to 2 years postoperative
PROMs scores for upper extremity pain interference
Patient-Reported Outcome Measures (PROMs) scores for upper extremity pain and how it interferes with the patients daily life. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher pain interference (worse).
Measured: Preoperative to 2 years postoperative
Shoulder Range of Motion
Standard range of motion values collected by the surgeon during preoperative and followup visits
Measured: Preoperative to 2 years postoperative
Shoulder Strength
Standard shoulder strength values collected by the surgeon during preoperative and followup visits. Medical Research Council Manual Muscle Testing scale will be used to measure the patient's strength on a 0 to 5 scale with 0 being the minimum and 5 being the maximum. Higher scores are better/normal.
Measured: Preoperative to 2 years postoperative
Complications
Both intra- and postoperative complications will be collected.
Measured: Intraoperative to 2 years postoperative
Reoperation
Whether or not patients required another operation.
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start16 Aug 2022
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into one of two groups. In the "control group," patients will receive the current surgical treatment for rotator cuff tears: debridement and repair. Patients in the "experimental group" will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in postoperative ultrasound imaging studies.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Muh, MD, Henry Ford Health System
- Investigators
- Stephanie J Muh, MC, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439850
- Sponsor's protocol ID
- 15702
- Status last verified
- Feb 2026
- First submitted
- 18 Jun 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05439850
- Acronym / sponsor ID
- 15702
- Conditions
- Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
- Keywords
- Rotator Cuff Tear, Bioinductive, Arthroscopic Rotator Cuff Repair, Rotator Cuff Tear Arthropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 30 Jun 2022 (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 randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.
Detailed description
A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non-surgical/conservative options for 6 weeks. Patients in the "control group" will receive the standard surgery (arthroscopic rotator cuff repair) . Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized into one of two groups. In the "control group," patients will receive the current surgical treatment for rotator cuff tears: debridement and repair. Patients in the "experimental group" will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in postoperative ultrasound imaging studies.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: arthroscopic rotator cuff repair, Diagnostic Test: Ultrasound ImagingSurgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year. |
| Study Group | Experimental | Procedure: arthroscopic rotator cuff repair, Biological: Bioinductive implant, Diagnostic Test: Ultrasound ImagingIdentical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Indicated and scheduled for arthroscopic rotator cuff repair.
- Full-thickness medium (1-3 cm), large (3-5 cm), and massive (>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
- Chronic, degenerative rotator cuff tears.
- Ability to read and understand English.
- Age ≥18 years
Key exclusion criteria (9 listed)
- Patient scheduled for open or mini-open rotator cuff repair
- Prior surgery of affected shoulder (except diagnostic arthroscopy)
- Partial-thickness rotator cuff tears
- Small (<1 cm) rotator cuff tears
- Rotator cuff tears involving the subscapularis tendon
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 |
|---|---|---|
| arthroscopic rotator cuff repairThis procedure is the standard of care for rotator cuff tears who fail conservative treatment options. | Procedure or surgery | Control Group, Study Group |
| Bioinductive implantAlso: Bioinductive patchA bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery. | Biological | Study Group |
| Ultrasound ImagingAn ultrasound will be performed on each patient one year postoperatively. | Diagnostic test | Control Group, Study Group |
Primary outcome
Rotator cuff repair integrity
Time frame: Preoperative to 1 year postoperative
absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.
7 secondary outcomes
PROMs scores for upper extremity function
Time frame: Preoperative to 2 years postoperative
PROMs scores for depression
Time frame: Preoperative to 2 years postoperative
PROMs scores for upper extremity pain interference
Time frame: Preoperative to 2 years postoperative
Shoulder Range of Motion
Time frame: Preoperative to 2 years postoperative
Shoulder Strength
Time frame: Preoperative to 2 years postoperative
Complications
Time frame: Intraoperative to 2 years postoperative
Reoperation
Time frame: 2 years postoperative
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 27 Feb 2026.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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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.
Stephanie J Muh, MD contact
Stephanie J Muh, MC principal investigator
Henry Ford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing arthroscopic rotator cuff repair, Bioinductive implant and Ultrasound Imaging in people with Rotator Cuff Tears and Rotator Cuff Tear Arthropathy, run by Henry Ford Health System 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 6 inclusion and 9 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 27 Feb 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Johnny Kasto, MD (313-244-8078, jkasto1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotator cuff repair integrity (time frame: Preoperative to 1 year postoperative). 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 27 Feb 2026.