Comparing a new graft to standard care for rotator cuff repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of the ActiveMatrix® graft in enhancing healing and shoulder function after arthroscopic rotator cuff repair surgery. Participants with full-thickness reparable rotator cuff tears will be treated with either the ActiveMatrix® graft or standard care. The study aims to determine if the new graft leads to better outcomes compared to traditional methods. Patients will be monitored for their recovery and functional improvements over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Eric F Berkman, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Eric F Berkman, MD
• Email: Eric.F.Berkman@uth.tmc.edu
• Phone: 713-314-4112

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Does age-related muscle loss change rotator cuff tear patterns?

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• Impact of neck nerve compression (cervical radiculopathy) on recovery after rotator cuff repair

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• Using virtual reality to help rehabilitate shoulder injuries

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  Recruiting La Tour Hospital · Meyrin, Canton of Geneva · NCT06963983

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.