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Accelerated Rehabilitation for Rotator Cuff Tears (iAccelerate Trial)
iAccelerate Trial Summary
This trial will study two accelerated rehabilitation programs for treating full thickness rotator cuff tears. The programs will be compared to see which is more effective.
iAccelerate Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowiAccelerate Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.iAccelerate Trial Design
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Who is running the clinical trial?
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- During the surgery, if your rotator cuff tear is fully repairable with good tissue and muscle quality, or if you have a partial tear of the supraspinatus, or if there is evidence of significant osteoarthritis, or if you need additional repairs such as subscapularis repair, labral repair, biceps tenodesis or if there is functional deficiency in coracoacromial ligament or shoulder instability is found, you will not be able to continue with the study.I have a diagnosed nerve or blood vessel disorder.My surgery revealed a tear larger than 5 cm involving two or more tendons.I have severe shoulder arthritis.I have a pre-existing issue with my shoulder muscle.I have had major joint issues, like trauma, infection, or tissue death.I have a partial tear in my shoulder tendon.I cannot move my shoulder muscle at all.I have had a shoulder dislocation in the last 5 years.I have a torn pectoralis or deltoid muscle due to injury.My shoulder condition does not qualify for this surgery due to its specific state or needs.I can walk on my own and can attend all follow-up visits and manage electronic records.My shoulder MRI shows a tear larger than 5 cm in at least two tendons, with pain over 30 mm on the VAS scale.I have a small, fixable tear in my shoulder's rotator cuff.I've tried medications, injections, physical therapy, rest, or activity changes for over 3 months without improvement.I am 65 years old or older.
- Group 1: Group I
- Group 2: Group II
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any vacancies in this medical research project?
"As displayed on clinicaltrials.gov, this research project is presently searching for volunteers to participate in the trial. This study was first advertised on February 7th 2022 and has recently been updated November 22nd 2022."
Are any medical centers in North America participating in this clinical trial?
"The Rothman Institute in Philadelphia, Pennsylvania, Holy Cross Hospital in Fort Lauderdale, Florida and Musculoskeletal-Orthopedic Research and Education Foundation in Phoenix, Arizona are the primary trial sites. Additionally there are 4 subsidiary locations participating as well."
What is the scope of enrollment for this research project?
"The sponsor, Stryker Endoscopy, will be recruiting a sum of 150 individuals who satisfy the clinical trial's qualifying conditions. To accomplish this goal, they'll draw from resources at The Rothman Institute in Philadelphia and Holy Cross Hospital in Fort Lauderdale."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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