Bioinductive Patch for Full-Thickness Rotator Cuff Tears
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: arthroscopic rotator cuff repair, Bioinductive implant, Ultrasound Imaging.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears, Rotator Cuff Tear Arthropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
Overview
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.
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.
Primary outcome measures
- Rotator cuff repair integrity [Time frame: Preoperative to 1 year postoperative]
Secondary outcome measures (7)
- PROMs scores for upper extremity function [Time frame: Preoperative to 2 years postoperative]
- PROMs scores for depression [Time frame: Preoperative to 2 years postoperative]
- PROMs scores for upper extremity pain interference [Time frame: Preoperative to 2 years postoperative]
- Shoulder Range of Motion [Time frame: Preoperative to 2 years postoperative]
- Shoulder Strength [Time frame: Preoperative to 2 years postoperative]
- Complications [Time frame: Intraoperative to 2 years postoperative]
- Reoperation [Time frame: 2 years postoperative]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Henry Ford Health — Detroit
Identifiers
NCT: NCT05439850 · 15702