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ActiveMatrix® for Rotator Cuff Repair

This study is looking at how well a product called ActiveMatrix® helps with healing and shoulder function after surgery for rotator cuff tears. You might be able to join if you are between 18 and 80 years old and have a specific type of rotator cuff tear that can be repaired. Participants will receive either one of two doses of ActiveMatrix® or a saline injection. The study will measure success by looking at changes in your shoulder's healing on MRI scans at 6 and 12 months after surgery. The current recruitment status is unclear.

Study design
This study plans to enroll 72 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months after surgery, with MRI scans at 6 and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05894265

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

Recruiting
NAAges 18–80InterventionalTreatment
The University of Texas Health Science Center, Houston
~72 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:ActiveMatrix® Dosage AActiveMatrix® Dosage BSaline injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Measured over 6 months post surgery , 12 months post surgery

Conditions

Rotator Cuff Tears

Explore related trials

Rupture of rotator cuff of shoulder

NCT05894265

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Texas Health Science Center at Houston

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Eric F Berkman, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Eric F Berkman, MD
[email protected]
713-314-4112
Email the study team

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Eligibility criteria

Inclusion

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)
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

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.

What this trial measures

  • Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)6 months post surgery , 12 months post surgery

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