Bioinductive Patch for Full-Thickness Rotator Cuff Tears

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Henry Ford Health

Status and phase

Enrolling
Phase 4

Conditions

Rotator Cuff Tear Arthropathy
Rotator Cuff Tears

Treatments

Procedure: arthroscopic rotator cuff repair
Diagnostic Test: Ultrasound Imaging
Biological: Bioinductive implant

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05439850
15702

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

78 participants in 2 patient groups

Control Group
Active Comparator group
Description:
Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.
Treatment:
Diagnostic Test: Ultrasound Imaging
Procedure: arthroscopic rotator cuff repair
Study Group
Experimental group
Description:
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
Treatment:
Biological: Bioinductive implant
Diagnostic Test: Ultrasound Imaging
Procedure: arthroscopic rotator cuff repair

Trial contacts and locations

1

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Central trial contact

Johnny Kasto, MD; Stephanie J Muh, MD

Data sourced from clinicaltrials.gov

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