Clinical trial NCT05439850: Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Official title: Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rotator Cuff Tears
Rotator Cuff Tear Arthropathy
Keywords: Rotator Cuff Tear
Bioinductive
Arthroscopic Rotator Cuff Repair
Rotator Cuff Tear Arthropathy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility 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

Primary outcomes:
measure: Rotator cuff repair integrity
timeFrame: Preoperative to 1 year postoperative
Secondary outcomes:
measure: PROMs scores for upper extremity function
timeFrame: Preoperative to 2 years postoperative
measure: PROMs scores for depression
timeFrame: Preoperative to 2 years postoperative
measure: PROMs scores for upper extremity pain interference
timeFrame: Preoperative to 2 years postoperative
measure: Shoulder Range of Motion
timeFrame: Preoperative to 2 years postoperative
measure: Shoulder Strength
timeFrame: Preoperative to 2 years postoperative
measure: Complications
timeFrame: Intraoperative to 2 years postoperative
measure: Reoperation
timeFrame: 2 years postoperative
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
affiliation: Henry Ford Health
name: Stephanie J Muh, MC
role: PRINCIPAL_INVESTIGATOR
References: