Arthroscopic Rotator Cuff Repair Augmented with Bioinductive Implant for Full-Thickness Tears: a Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- arthroscopic rotator cuff repair
- Conditions
- Rotator Cuff Tears
- Sponsor
- Henry Ford Health System
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Rotator cuff repair integrity
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Stephanie Muh, MD
Deputy Service Chief, Principal Investigator
Henry Ford Health System
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
- •Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
Arms & Interventions
Control Group
Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.
Intervention: arthroscopic rotator cuff repair
Control Group
Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.
Intervention: Ultrasound Imaging
Study Group
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
Intervention: arthroscopic rotator cuff repair
Study Group
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
Intervention: Bioinductive implant
Study Group
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
Intervention: Ultrasound Imaging
Outcomes
Primary Outcomes
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
- PROMs scores for upper extremity function(Preoperative to 2 years postoperative)
- PROMs scores for upper extremity pain interference(Preoperative to 2 years postoperative)
- Shoulder Range of Motion(Preoperative to 2 years postoperative)
- Reoperation(2 years postoperative)
- PROMs scores for depression(Preoperative to 2 years postoperative)
- Shoulder Strength(Preoperative to 2 years postoperative)
- Complications(Intraoperative to 2 years postoperative)