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Extracellular Matrix Graft

ECM Scaffold Graft for Rotator Cuff Tears

Phase 4
Waitlist Available
Led By Gregory J Gilot, MD
Research Sponsored by Gregory Gilot
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a large (3-5 cm) to massive (>5 cm) rotator cuff tear who will be undergoing open or arthroscopic repair. The cuff tear size will be determined on pre-operative MRI and US.
Patients who meet criteria for RCR surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up as assessed at 1 year postoperatively.
Awards & highlights

Study Summary

This trial is to see if the ArthroFLEX® ECM scaffold graph can help reduce the failure rate for large and massive rotator cuff tears.

Who is the study for?
This trial is for adults over 18 with large to massive rotator cuff tears who need surgery. They must be able to consent and not be prisoners, pregnant, nursing, or have a history of substance abuse treatment failure. Exclusion also applies to those with infections or health conditions that risk their safety in the study.Check my eligibility
What is being tested?
The trial tests if adding an ArthroFLEX ECM scaffold graft during repair surgery can lower the chance of rotator cuff repairs failing in patients with significant tears. Participants will either receive this graft or go through standard care without it.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include typical surgical complications such as infection at the site, pain, swelling, and adverse reactions to the graft material used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a large to massive tear in my rotator cuff confirmed by MRI or US, and will undergo repair.
Select...
I am eligible for surgery to remove my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~as assessed at 1 year postoperatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and as assessed at 1 year postoperatively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of healing by MRI vs US
Progress of tendon healing
Tendon healing
Secondary outcome measures
Patient Outcomes: Constant Score (CS)
Shoulder
Patient Outcomes: Subjective Shoulder Value (SSV)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Crossover GroupExperimental Treatment2 Interventions
Patients initially randomized to the control arm who cannot be repaired without an augmented graft will be followed for safety and remain in the study and put into a group for the intention to treat.
Group II: Control GroupActive Control1 Intervention
Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used.
Group III: Treatment GroupActive Control2 Interventions
Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair and the surgeon will use the ArthroFLEX® ECM graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control
2011
Completed Phase 4
~15780
Crossover
2013
N/A
~270

Find a Location

Who is running the clinical trial?

Gregory GilotLead Sponsor
LifeNet HealthIndustry Sponsor
14 Previous Clinical Trials
1,222 Total Patients Enrolled
The Cleveland ClinicOTHER
1,026 Previous Clinical Trials
1,366,006 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
175 Patients Enrolled for Rotator Cuff Tears

Media Library

ArthroFLEX ECM scaffold graft (Extracellular Matrix Graft) Clinical Trial Eligibility Overview. Trial Name: NCT03551509 — Phase 4
Rotator Cuff Tears Research Study Groups: Control Group, Treatment Group, Crossover Group
Rotator Cuff Tears Clinical Trial 2023: ArthroFLEX ECM scaffold graft Highlights & Side Effects. Trial Name: NCT03551509 — Phase 4
ArthroFLEX ECM scaffold graft (Extracellular Matrix Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03551509 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Treatment Group have the official sanction of the FDA?

"The Treatment Group is deemed safe enough to warrant a score of 3, as it has been approved for use in Phase 4 trials."

Answered by AI

What ailments does Treatment Group usually treat?

"Treatment Group is a viable option for managing symptoms of osteoarthritis, joint ache, and lower back discomfort."

Answered by AI

Is enrollment open for this medical experiment at present?

"The clinical trial's current status is recruiting, as per the information hosted on clinicaltrials.gov. The investigation was initially announced on 7/1/2018 and has been revised most recently on 10/13/2022."

Answered by AI

What is the desired outcome of this research endeavor?

"According to LifeNet Health, the primary objective of this trial is tendon healing and will be measured post-operatively at 1 year. Additional secondary objectives include Patient Outcomes: Measurement of Shoulder Activity Level (a numerical sum of scores for five activities rated on a 5 point frequency scale), The American Shoulder and Elbow Surgeon Shoulder Score (ASES) which assesses range of motion, physical signs, strength, and stability), and Subjective Shoulder Value (SSV; patient's subjective assessment expressed as a % of an entirely normal shoulder)."

Answered by AI

How many participants are involved in the experiment?

"Affirmative. According to the records stored on clinicaltrials.gov, this trial is actively enrolling patients and has been since July 1st 2018. The last modification was made on October 13th 2022 with an aim of recruiting 70 individuals across a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair
Gregory Gilot 2018. "LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03551509.
~2 spots leftby Jun 2024
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