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New treatment option for Rotator Cuff Tears of the Shoulder
Official title Integrity Implant System Post Market Clinical Follow-Up Study
ClinicalTrials.gov ID: NCT06741527
What this study is testing
- What it's testing
- The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years of age
- Able (with assistance from LAR, if necessary) to understand the informed consent process, including regulatory requirements such as HIPAA...
- Able to complete all Patient Reported Outcome Measure (PROM) questionnaires.
- Fully understands study requirements and able to return for all required follow-up visits and assessments.
- Able to comply with all post-operative physician prescribed rehabilitation instructions.
You likely can't join if
- The subject exclusion criteria are as follows:
- Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
- Vulnerable population (prisoners, minors, pregnant women, mentally ill persons and the elderly or any person under any undue pressure from others to...
- Pregnant, breastfeeding, or plans to become pregnant during the study
- History of poor compliance with medical treatment of any kind
- Deemed contraindicated for MRI by the PI
See the full eligibility criteria
- At least 18 years of age
- Able (with assistance from LAR, if necessary) to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any...
- Able to complete all Patient Reported Outcome Measure (PROM) questionnaires.
- Fully understands study requirements and able to return for all required follow-up visits and assessments.
- Able to comply with all post-operative physician prescribed rehabilitation instructions.
- Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention
- Meets all intended use and indications for use defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include: Index shoulder rotator cuff tendon tear needs management and...
- The subject exclusion criteria are as follows:
- Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
- Vulnerable population (prisoners, minors, pregnant women, mentally ill persons and the elderly or any person under any undue pressure from others to participate in the study)
- Pregnant, breastfeeding, or plans to become pregnant during the study
- History of poor compliance with medical treatment of any kind
- Deemed contraindicated for MRI by the PI
- Previous rotator cuff surgery (any type) on the index shoulder
- Current instability of the index shoulder
- Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length \>5cm)
- Chondromalacia of index shoulder ≥ Grade 3
- Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
- Insulin dependent Type I Diabetes
- History of heavy smoking (≥ 1 pack per day) within last 6-months
- History of auto-immune or immunodeficiency disorders
- Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)
- Oral steroid use in the last 2-months or injectable steroid use in the last 3-months
- History of cognitive or mental health status that interferes with study participation
- Poor comprehension of English language
- Meets one or more of the contraindications defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include: 18.1 Rotator cuff tendon tear is deemed irreparable by the PI 18.2...
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Pomona, California, United States
- Tampa, Florida, United States
- Rome, Georgia, United States
- Fishers, Indiana, United States
- Towson, Maryland, United States
- Marlton, New Jersey, United States
- Greenville, South Carolina, United States
- Germantown, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Pomona, California, United States; Tampa, Florida, United States; Rome, Georgia, United States; Fishers, Indiana, United States; Towson, Maryland, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.