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NCT Number: NCT05439850

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

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.

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Key information

Conditions

Rotator Cuff Tears Arthritis Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases Rotator Cuff Injuries Rotator Cuff Tear Arthropathy Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

Johnny Kasto, MD

CONTACT

[email protected]

3132448078

Stephanie J Muh, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Rotator Cuff Repair

Procedure

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

Bioinductive implant

Biological

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

Other names: Bioinductive patch

Ultrasound imaging

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. PROMs scores for upper extremity function

    Time frame: Preoperative to 2 years postoperative

    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.

  2. PROMs scores for depression

    Time frame: Preoperative to 2 years postoperative

    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).

  3. PROMs scores for upper extremity pain interference

    Time frame: Preoperative to 2 years postoperative

    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).

  4. Shoulder Range of Motion

    Time frame: Preoperative to 2 years postoperative

    Standard range of motion values collected by the surgeon during preoperative and followup visits

  5. Shoulder Strength

    Time frame: Preoperative to 2 years postoperative

    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.

  6. Complications

    Time frame: Intraoperative to 2 years postoperative

    Both intra- and postoperative complications will be collected.

  7. Reoperation

    Time frame: 2 years postoperative

    Whether or not patients required another operation.

Study contacts

Contact information is provided by the study sponsor or research team.

Johnny Kasto, MD

CONTACT

[email protected]

313-244-8078

Stephanie J Muh, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Jun 30, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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