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

May 30, 2023 updated by: Eric F Berkman, The University of Texas Health Science Center, Houston

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline Injection
Procedure: Saline injection
Group 3 will receive saline injection
Experimental: ActiveMatrix® Dosage A
Other: ActiveMatrix® Dosage A
This group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline)
Other Names:
  • Human Placental Connective Tissue-Derived Allograft
Experimental: ActiveMatrix® Dosage B
Other: ActiveMatrix® Dosage B
Group 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline)
Other Names:
  • Human Placental Connective Tissue-Derived Allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Time Frame: 6 months post surgery , 12 months post surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer
Time Frame: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.PROM will be measured on both sides
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)
Time Frame: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
The total score is weighted 50% for pain and 50% for function. The pain score is calculated by subtracting the VAS from 10 and multiplying it by 5. The 10 functional questions are scored on a 4-point scale (0-3) with a maximum functional score of 30. The raw functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points. The pain and function scores are then added together to obtain the final ASES score (out of 100). Higher scores correlate to better outcomes.
baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
Time Frame: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
VAS is scored on a 100mm horizontal scale that represents the patients pain intensity. A higher score corresponds to increased pain intensity
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)
Time Frame: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. This contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability and each is scored from 0 = no pain and 10 = the worst pain imaginable. SPADI is scored from 0 to 130 with a high score representing more pain and disability.
baseline, 4weeks, 3 months, 6 months 9 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Skye Biologics

Investigators

  • Principal Investigator: Eric F Berkman, MD, 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 Major Dates

Study Start (Estimated)

June 5, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-23-0312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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