Clinical Trial Finder

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
  • - Active infection.
  • - Cancer.
- Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05439850
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Henry Ford Health System
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Stephanie J Muh, MC
Principal Investigator Affiliation Henry Ford Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Control Group

Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.

Experimental: Study Group

Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.

Interventions

Procedure: - arthroscopic rotator cuff repair

This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.

Biological: - Bioinductive implant

A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.

Diagnostic Test: - Ultrasound Imaging

An ultrasound will be performed on each patient one year postoperatively.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Henry Ford Health, Detroit, Michigan

Status

Recruiting

Address

Henry Ford Health

Detroit, Michigan, 48202

Site Contact

Johnny Kasto, MD

[email protected]

313-244-8078

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