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

NCT05894265 | Recruiting

• 1 other identifier: HSC-MS-23-0312
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

musculoskeletal injuries; rotator cuff repair

Outcome Measures

Primary Outcomes (1)

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

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

  6 months post surgery , 12 months post surgery

Secondary Outcomes (4)

• 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 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 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

Study Arms (3)

ActiveMatrix® Dosage A

EXPERIMENTAL

Other: ActiveMatrix® Dosage A

ActiveMatrix® Dosage B

EXPERIMENTAL

Other: ActiveMatrix® Dosage B

Saline Injection

PLACEBO COMPARATOR

Procedure: Saline injection

Interventions

ActiveMatrix® Dosage A OTHER

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

Also known as: Human Placental Connective Tissue-Derived Allograft

ActiveMatrix® Dosage A

ActiveMatrix® Dosage B OTHER

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

Also known as: Human Placental Connective Tissue-Derived Allograft

ActiveMatrix® Dosage B

Saline injection PROCEDURE

Group 3 will receive saline injection

Saline Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Skye Biologics Holdings, LLC: collaborator
• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Eric F Berkman, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric F Berkman, MD

CONTACT

713-314-4112; Eric.F.Berkman@uth.tmc.edu

Layla Haidar

CONTACT

713-486-5529; Layla.Haidar@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: June 14, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)