Bioinductive Patch for Full-Thickness Rotator Cuff Tears

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Primary Purpose

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

arthroscopic rotator cuff repair

Bioinductive implant

Ultrasound Imaging

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Rotator Cuff Tear, Bioinductive, Arthroscopic Rotator Cuff Repair, Rotator Cuff Tear Arthropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Henry Ford HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Study Group

Arm Description

Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.

Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.

Outcomes

Primary Outcome Measures

Rotator cuff repair integrity

absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.

Secondary Outcome Measures

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.

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).

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).

Shoulder Range of Motion

Standard range of motion values collected by the surgeon during preoperative and followup visits

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.

Complications

Both intra- and postoperative complications will be collected.

Reoperation

Whether or not patients required another operation.

Full Information

NCT ID

NCT05439850

First Posted

June 18, 2022

Last Updated

May 17, 2023

Sponsor

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT05439850

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 16, 2022 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tears, Rotator Cuff Tear Arthropathy

Keywords

Rotator Cuff Tear, Bioinductive, Arthroscopic Rotator Cuff Repair, Rotator Cuff Tear Arthropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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.

Masking

Participant

Masking Description

The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.

Arm Title

Study Group

Arm Type

Experimental

Arm Description

Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.

Intervention Type

Procedure

Intervention Name(s)

arthroscopic rotator cuff repair

Intervention Description

This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.

Intervention Type

Biological

Intervention Name(s)

Bioinductive implant

Other Intervention Name(s)

Bioinductive patch

Intervention Description

A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.

Intervention Type

Diagnostic Test

Intervention Name(s)

Ultrasound Imaging

Intervention Description

An ultrasound will be performed on each patient one year postoperatively.

Primary Outcome Measure Information:

Title

Rotator cuff repair integrity

Description

absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.

Time Frame

Preoperative to 1 year postoperative

Secondary Outcome Measure Information:

Title

PROMs scores for upper extremity function

Description

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.

Time Frame