Status:
ACTIVE_NOT_RECRUITING
MPM Medical CoMatryx Surgical Bovine Collagen Study
Lead Sponsor:
MPM Medical
Collaborating Sponsors:
Texas Health Resources
Conditions:
Surgical Wound, Healed
Eligibility:
All Genders
18-85 years
Brief 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 co...
Detailed Description
The CoMatryx Surgical Collagen powder is a soft tissue repair product made of 100% Type I Bovine collagen. It is non-hydrolyzed and not cross-linked chemically. It is biocompatible, biodegradable and ...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
September 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 2 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04407364
Start Date
September 2 2020
End Date
May 2 2025
Last Update
July 5 2024
Active Locations (1)
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1
Texas Center for Joint Replacement
Plano, Texas, United States, 75093