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Device
Accelerated Rehabilitation for Rotator Cuff Tears (iAccelerate Trial)
N/A
Recruiting
Research Sponsored by Stryker Endoscopy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intra-operative Inclusion Criteria: Full thickness tear, Tear size ≥ 5 cm in diameter, Tear involving ≥ two tendons
Must be independent, ambulatory, and can comply with all post-operative evaluations, visits, and electronic database collection
Must not have
The subject requires concomitant: Subscapularis repair, Labral repair of any type, Biceps tenodesis, Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy, The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder, Major medical condition that could affect quality of life and influence the results of the study (e.g., rheumatoid arthritis), The subject has documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment, The subject's condition represents a worker's compensation case, The subject is currently involved in a health-related litigation procedure, Females of child-bearing potential who are pregnant or plan to become pregnant, Concurrent participation in an investigational clinical study one month prior to enrollment or during the entire study period, The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up, The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition, The subject currently has an acute infection in the area surrounding the surgical site, Baseline WORC score less than 420
Known neurovascular compromise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12 and month 24
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for people aged 65 or older with massive, irreparable rotator cuff tears that are at least 5 cm wide and involve two or more tendons. They must have tried non-surgical treatments like painkillers, anti-inflammatories, steroid injections, physical therapy, or rest without success. Participants need to be in good health overall, able to walk and take care of themselves post-surgery.
What is being tested?
The study is testing two different accelerated rehabilitation programs after the surgical placement of an InSpace device—a subacromial tissue spacer—during arthroscopy for large rotator cuff tears. It's a randomized trial comparing how patients recover with each program.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, inflammation around the shoulder area due to the device or surgery itself. There could also be risks associated with anesthesia during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgery revealed a tear larger than 5 cm involving two or more tendons.
Select...
I can walk on my own and can attend all follow-up visits and manage electronic records.
Select...
My shoulder MRI shows a tear larger than 5 cm in at least two tendons, with pain over 30 mm on the VAS scale.
Select...
I am 65 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a diagnosed nerve or blood vessel disorder.
Select...
I have severe shoulder arthritis.
Select...
I have a pre-existing issue with my shoulder muscle.
Select...
I have had major joint issues, like trauma, infection, or tissue death.
Select...
I have a partial tear in my shoulder tendon.
Select...
I cannot move my shoulder muscle at all.
Select...
I have a torn pectoralis or deltoid muscle due to injury.
Select...
My shoulder condition does not qualify for this surgery due to its specific state or needs.
Select...
I have a small, fixable tear in my shoulder's rotator cuff.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12 and month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12 and month 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Elbow
Secondary study objectives
Analgesia Use
Change in Constant Score (CS) Outcome Score
Change in EuroQol 5-Dimensions Questionnaire (EQ-5D-5L) Score
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group IIExperimental Treatment1 Intervention
InSpace device + accelerated rehabilitation in an at-home program (AHP)
Group II: Group IExperimental Treatment1 Intervention
InSpace device + accelerated rehabilitation in a formalized program (FP)
Find a Location
Who is running the clinical trial?
Stryker EndoscopyLead Sponsor
4 Previous Clinical Trials
1,870 Total Patients Enrolled
Colleen Roden, MSStudy DirectorStryker Endoscopy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Group I
- Group 2: Group II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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