MPM Medical CoMatryx Surgical Bovine Collagen Study (NCT04407364) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MPM Medical CoMatryx Surgical Bovine Collagen Study
United States72 participantsStarted 2020-09-02
Plain-language summary
The objective of this prospective enrollment study is to collect data confirming safety, performance and clinical benefits of the CoMatryx Surgical Collagen powder at a minimum 1-year follow-up and compare it to a historical control group who did not receive the product at the time of surgery.
The primary objective is to confirm safety and clinical benefits of the product. This will be assessed by recording the rate of wound healing and incidence and frequency of wound care related complications. Relationship of complications to the product should be specified.
Who can participate
Age range
18 Years – 85 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:
* • Subjects must be 18 years of age or older
* Subject must be willing and able to sign IRB approved informed consent
* Subject must have a BMI of 35 or higher
* Surgical approach of only ASI (anterior supine)
* Primary total hip arthroplasty
* Revision total hip arthroplasty
Exclusion Criteria:
* • Subjects more than 85 years of age
* Subjects who will be or have undergone bilateral total hip replacements
* Subject is known to be pregnant or nursing
* Subject is an alcohol or drug abuser
* Subject has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
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
CoMatryx Surgical Bovine Collagen
Timeframe: This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.
2
CoMatryx Surgical Bovine Collagen Height and Weight
Timeframe: This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.