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Connective Tissue Allograft
ActiveMatrix for Rotator Cuff Repair
N/A
Waitlist Available
Led By Eric F Berkman, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Awards & highlights
Study Summary
This trial looks at how a new graft helps heal and improve shoulder function after rotator cuff repair surgery.
Who is the study for?
This trial is for adults with a specific type of shoulder injury called a full-thickness rotator cuff tear, who have tried physical therapy or exercises without success. They must be able to follow the study's procedures and attend all follow-ups. People can't join if they've had certain other shoulder issues, recent surgery on that shoulder, are involved in litigation related to injuries, have chronic pain disorders like fibromyalgia, substance abuse problems, or women who are pregnant or not using contraception.Check my eligibility
What is being tested?
The study tests how well ActiveMatrix® graft helps heal and improve function after rotator cuff repair surgery compared to just saline injection (standard care). Participants will receive one of two different doses of ActiveMatrix® or a saline injection during their surgery.See study design
What are the potential side effects?
While the side effects aren't specified here, similar treatments may cause discomfort at the injection site, swelling, infection risk increase around the operated area and possible allergic reactions to materials used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Secondary outcome measures
Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI)
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveMatrix® Dosage BExperimental Treatment1 Intervention
Group II: ActiveMatrix® Dosage AExperimental Treatment1 Intervention
Group III: Saline InjectionPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,917 Total Patients Enrolled
Skye BiologicsUNKNOWN
1 Previous Clinical Trials
275 Total Patients Enrolled
Eric F Berkman, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have advanced shoulder arthritis according to the Samilson-Prieto classification.I am not pregnant, breastfeeding, or planning to become pregnant, and I can use birth control during the study.I had surgery on my shoulder within the last year, including procedures like Latarjet or rotator cuff repair.I tried physical therapy or exercises for 4-6 weeks for my shoulder tear but it didn't help.I have not had a steroid injection in my shoulder in the last 6 weeks.I have 1 or 2 full thickness tears in my rotator cuff that can be repaired.My shoulder injury can be fixed by reattaching the tendon with little tension.I am not allergic to or advised against the trial treatment.I am ready and able to follow the physical therapy and study check-up plan.I have a major tear in my shoulder muscle but the muscle in front is not affected.I have recent shoulder images to check for other causes of my symptoms.I have had cancer that spread to my bones.My shoulder muscle has significant fat content.I have calcific tendonitis in my shoulder.I have a history of bone growth in abnormal places.I have an injury on my opposite shoulder that could affect my shoulder surgery recovery.I had surgery to fix bone defects in my shoulder that required an implant.I need surgery for a significant tear in my shoulder tendon.I have a chronic pain disorder like fibromyalgia.
Research Study Groups:
This trial has the following groups:- Group 1: ActiveMatrix® Dosage A
- Group 2: ActiveMatrix® Dosage B
- Group 3: Saline Injection
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment stage of this clinical trial still active?
"According to the info on clinicaltrials.gov, this trial is no longer accepting candidates. The study was first published in June 5th 2023 and has not been updated since May 30th 2023. However, there are a plethora of other medical trials that currently need participants right now with 114 registered so far."
Answered by AI
Does this experiment provide opportunities for seniors to participate?
"Candidates who are 18 years of age or older, but not beyond their 75th birthday can take part in this clinical trial."
Answered by AI
Who has the opportunity to participate in this medical experiment?
"Admittance to this particular trial necessitates participants have a torn rotator cuff and are aged 18-75. Currently, there remain 60 spaces for enrolment in the study."
Answered by AI
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