Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (Active Matrix) vs. Standard of Care in Arthroscopic Rotator Cuff Repair

The University of Texas Health Science Center, Houston2 sites in 1 country72 target enrollmentJune 14, 2023

ConditionsRotator Cuff Tears

InterventionsActiveMatrix® Dosage A ActiveMatrix® Dosage B Saline injection

Overview

Phase: N/A
Intervention: ActiveMatrix® Dosage A
Conditions: Rotator Cuff Tears
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 72
Locations: 2
Primary Endpoint: Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Status: Recruiting
Last Updated: 3 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery

Registry

clinicaltrials.gov

Start Date

June 14, 2023

End Date

August 1, 2026

Last Updated

3 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Eric F Berkman

Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

•Provision of signed and dated informed consent form
•Stated willingness to comply with all study procedures and availability for the duration of the study
•1-2 tendon full thickness reparable rotator cuff tendon tear(s)
•Reparable tear defined as:
•a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension.
•Full-thickness tear defined as:
•a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border
•Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
•Have no contraindications or allergies to the treatment administered
•Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses

Exclusion Criteria

•Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
•Prior surgery for bone defects requiring bone implantation in the index shoulder,
•Steroid injection into the index shoulder within 6 weeks of enrollment.
•Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
•Calcific tendonitis in the index shoulder,
•Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3,
•Contralateral shoulder injury that may interfere with the post-operative rotator cuff repair rehab guidelines,
•History of advanced osteoarthritis of glenohumeral joint (AC joint can have advanced OA) i.e. Samilson-Prieto classification ≥ Grade 2
•History of malignant tumor and osseous metastatic disease,
•History of heterotopic ossification,

Arms & Interventions

ActiveMatrix® Dosage A

Intervention: ActiveMatrix® Dosage A

ActiveMatrix® Dosage B

Intervention: ActiveMatrix® Dosage B

Saline Injection

Intervention: Saline injection

Outcomes

Primary Outcomes

Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)

Time Frame: 6 months post surgery , 12 months post surgery

Sugaya classification is a classification system that is used to analyze postoperative rotator cuff tendon integrity

Secondary Outcomes

Change in shoulder function as assessed by the American Shoulder and Elbow Surgeons Shoulder Score (ASES)(baseline, 4weeks, 3 months, 6 months 9 months, and 12 months)
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer(baseline, 4weeks, 3 months, 6 months 9 months, and 12 months)
Change in pain intensity as assessed by the Visual Analog Scale (VAS)(baseline, 4weeks, 3 months, 6 months 9 months, and 12 months)
Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI)(baseline, 4weeks, 3 months, 6 months 9 months, and 12 months)