Treatment Group for Rotator Cuff Tears

Phase-Based Progress Estimates
Cleveland Clinic Florida, Weston, FLRotator Cuff TearsArthroFLEX ECM scaffold graft - Biological
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Rotator Cuff Tears

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: As assessed at 1 year postoperatively.

Year 1
Comparison of healing by MRI vs US
Tendon healing
Year 1
Progress of tendon healing
Year 1
Patient Outcomes: Constant Score (CS)
Patient Outcomes: Subjective Shoulder Value (SSV)
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
Erythrocyte Indices

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Control Group
1 of 2
Treatment Group
1 of 2

Active Control

70 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment Group · No Placebo Group · Phase 4

Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:
Treatment GroupActiveComparator Group · 2 Interventions: ArthroFLEX ECM scaffold graft, Control · Intervention Types: Biological, Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: as assessed at 1 year postoperatively.

Who is running the clinical trial?

Gregory GilotLead Sponsor
LifeNet HealthIndustry Sponsor
11 Previous Clinical Trials
1,058 Total Patients Enrolled
The Cleveland ClinicOTHER
959 Previous Clinical Trials
1,363,993 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
175 Patients Enrolled for Rotator Cuff Tears
Gregory J Gilot, MDPrincipal InvestigatorCleveland Clinic Florida

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible for RCR surgery.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

What ailments does Treatment Group usually treat?

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

Unverified Answer

Is enrollment open for this medical experiment at present?

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

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer

How many participants are involved in the experiment?

"Affirmative. According to the records stored on, 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.