RECRUITING

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

Conditions

Rotator Cuff Tears musculoskeletal injuries rotator cuff repair

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-06-14

Study Completion:2025-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05894265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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) * 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	* 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.

Inclusion Criteria

Exclusion 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)
* 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

* 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Eric F Berkman, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-14

Study Completion Date2025-06-01

Study Record Updates

Study Start Date2023-06-14

Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

musculoskeletal injuries
rotator cuff repair

Additional Relevant MeSH Terms

Rotator Cuff Tears