Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439850
• Other study ID #: 15702
• Status: Recruiting
• Phase: Phase 4
• Start date: August 16, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: Henry Ford Health System
• Contact: Johnny Kasto, MD
• Phone: 313-244-8078
• Email: jkasto1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy
• Rotator Cuff Tears

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Health	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotator cuff repair integrity	absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.	Preoperative to 1 year postoperative
Secondary	PROMs scores for upper extremity function	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.	Preoperative to 2 years postoperative
Secondary	PROMs scores for depression	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).	Preoperative to 2 years postoperative
Secondary	PROMs scores for upper extremity pain interference	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).	Preoperative to 2 years postoperative
Secondary	Shoulder Range of Motion	Standard range of motion values collected by the surgeon during preoperative and followup visits	Preoperative to 2 years postoperative
Secondary	Shoulder Strength	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.	Preoperative to 2 years postoperative
Secondary	Complications	Both intra- and postoperative complications will be collected.	Intraoperative to 2 years postoperative
Secondary	Reoperation	Whether or not patients required another operation.	2 years postoperative