CompletedNot Applicable

Post-Market Evaluation of the Rotation Medical Rotator Cuff System

United States148 participantsStarted 2014-08-20

Plain-language summary

The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least 21 years of age
. Rotator cuff tear requiring surgery that meets either criterion A or B:
. Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
. MRI of the shoulder within 60 days prior to the study procedure
. Willing to comply with the prescribed post-operative rehabilitation program
. Willing to be available for each protocol-required follow-up examination
. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Tendon Thickness

Timeframe: Pre-operatively (baseline) to 3 month, 1 year, and 2 year

Integration of Induced Tissue With Underlying Tendon

Timeframe: 3 months, 1 year, and 2 years

Fill-In of Partial Thickness Tears and Underlying Tendon Quality

Timeframe: 3 months, 1 year, and 2 years

Number of Participants With a Re-Tear

Timeframe: 3 months, 1 year, and 2 years

Trial details

NCT IDNCT02200939

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-24

Results submitted2021-11-18

View on ClinicalTrials.gov More Partial Thickness Supraspinatus Tendon Tear trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least 21 years of age
. Rotator cuff tear requiring surgery that meets either criterion A or B:
. Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
. MRI of the shoulder within 60 days prior to the study procedure
. Willing to comply with the prescribed post-operative rehabilitation program
. Willing to be available for each protocol-required follow-up examination
. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures

What they're measuring

Change in Tendon Thickness

Timeframe: Pre-operatively (baseline) to 3 month, 1 year, and 2 year

Integration of Induced Tissue With Underlying Tendon

Timeframe: 3 months, 1 year, and 2 years

Fill-In of Partial Thickness Tears and Underlying Tendon Quality

Timeframe: 3 months, 1 year, and 2 years

Number of Participants With a Re-Tear

Timeframe: 3 months, 1 year, and 2 years

Post-Market Evaluation of the Rotation Medical Rotator Cuff System

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Post-Market Evaluation of the Rotation Medical Rotator Cuff System

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria