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

NCT ID: NCT05894265

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2026-08-01

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

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ActiveMatrix® Dosage A

Group Type: EXPERIMENTAL

ActiveMatrix® Dosage A

Intervention Type: OTHER

This group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline)

ActiveMatrix® Dosage B

Group Type: EXPERIMENTAL

ActiveMatrix® Dosage B

Intervention Type: OTHER

Group 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline)

Saline Injection

Group Type: PLACEBO_COMPARATOR

Saline injection

Intervention Type: PROCEDURE

Group 3 will receive saline injection

Interventions

ActiveMatrix® Dosage A

This group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline)

Intervention Type: OTHER

ActiveMatrix® Dosage B

Group 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline)

Intervention Type: OTHER

Saline injection

Group 3 will receive saline injection

Intervention Type: PROCEDURE

Other Intervention Names

Human Placental Connective Tissue-Derived Allograft; Human Placental Connective Tissue-Derived Allograft

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
• Able and willing to comply with the post-operative physical therapy and study follow-up schedule

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,
• History of chronic pain disorders (i.e., fibromyalgia),
• Current substance abuse (drug or alcohol), by the investigator's judgment,
• For females of child-bearing potential: unable or unwilling to take adequate contraceptive precautions during the study, known to be pregnant at enrollment, breastfeeding an infant at enrollment or during the study, or planning to become pregnant during the study,
• Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,
• Currently involved in any injury litigation or workers compensation claims,
• has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Skye Biologics Holdings, LLC

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Eric F Berkman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric F Berkman, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eric F Berkman, MD

Role: CONTACT

Eric.F.Berkman@uth.tmc.edu

713-314-4112

Layla Haidar

Role: CONTACT

Layla.Haidar@uth.tmc.edu

713-486-5529

Facility Contacts

Eric F Berkman, MD

Role: primary

Eric.F.Berkman@uth.tmc.edu

713-314-4112

Layla Haidar

Role: backup

Layla.Haidar@uth.tmc.edu

713-486-5529

Other Identifiers

HSC-MS-23-0312

Identifier Type: -

Identifier Source: org_study_id