LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair
Stopped: Sponsor terminated early
United States9 participantsStarted 2018-07-01
Plain-language summary
This trial is to evaluate the effectiveness of the ArthroFLEX® ECM scaffold graph as an augment in rotator cuff repair surgery to reduce the failure rate of rotator cuff repairs for large and massive rotator cuff tears.
Who can participate
Age range
18 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:
* Patients with a large (2.5-5 cm) to massive (\>5 cm) rotator cuff tear who will be undergoing open or arthroscopic repair. The cuff tear size will be determined on either pre-operative magnetic resonance imaging (MRI), or ultrasound (US), or intra-operative measurements, or computerized tomography (CT).
* Patients who are willing and able to provide written informed consent for their involvement in the study.
* Patients who meet criteria for RCR surgery
* Patients older than 18 years of age
Exclusion Criteria:
* Those with a known sensitivity to materials of porcine origin.
* Patients with addiction to illegal drugs, solvents or alcohol who are actively using or have previously attempted and failed a treatment program.
* Patients with bacteremia, a systemic infection, or infection of the surgical site.
* All those who are prisoners.
* Patients who are pregnant or nursing.
* All those with a condition that may limit a patient's ability to finalize the study or that may cause an undue risk to the patient's health and well-being.
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
1
Tendon Healing
Timeframe: As assessed 1 year postoperatively.
2
Comparison of Healing by MRI vs US
Timeframe: As assessed 1 year postoperatively.
3
Progress of Tendon Healing
Timeframe: As assessed at 6 weeks postoperatively.
4
Progress of Tendon Healing
Timeframe: As assessed at 3 months postoperatively.
5
Progress of Tendon Healing
Timeframe: As assessed at 6 months postoperatively.
6
Progress of Tendon Healing
Timeframe: As assessed at 9 months postoperatively.