Isolated Bioinductive Repair for Rotator Cuff Tears

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research St. Joseph's, Hamilton, Canada
Rotator Cuff Tears
Isolated Bioinductive Repair - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 25 Secondary · Reporting Duration: 1, 3 and 6 weeks, 3, 6, 12 and 24 months

Month 3
Duration of shoulder immobilization following index surgery
Month 24
Incidence of Revision Surgery
12 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score
Month 24
Patient Satisfaction
Month 24
Change in Constant-Murley Score
Change in Subjective Shoulder Value (SSV) score
Month 24
Change in Western Ontario Rotator Cuff (WORC)
Day 1-14
Cumulative days of opioid use
Inter-operative time
Total operative time
Month 24
Pain, Visual analog scale (VAS) Score
Month 24
EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores
Month 24
Constant-Murley Score
Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score
Month 24
Percent Achieving MCID for Subjective Shoulder Value (SSV) score
Subjective Shoulder Value (SSV) score
Month 24
Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)
Western Ontario Rotator Cuff (WORC)
Up to 24 months
Physical Therapy Utilization
Time to return to driving
Time to return to sports
Time to return to work

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Completion and Repair
1 of 2
Isolated Bioinductive Repair
1 of 2
Active Control
Experimental Treatment

156 Total Participants · 2 Treatment Groups

Primary Treatment: Isolated Bioinductive Repair · No Placebo Group · N/A

Isolated Bioinductive Repair
Device
Experimental Group · 1 Intervention: Isolated Bioinductive Repair · Intervention Types: Device
Completion and Repair
Procedure
ActiveComparator Group · 1 Intervention: Completion and Repair · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1, 3 and 6 weeks, 3, 6, 12 and 24 months
Closest Location: Research St. Joseph's · Hamilton, Canada
N/AFirst Recorded Clinical Trial
0 TrialsResearching Rotator Cuff Tears
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are not older than 18 years of age.\n
You are able to follow instructions and complete all study questionnaires.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.