Status:
UNKNOWN
FastThread Interference Screws
Lead Sponsor:
Arthrex, Inc.
Collaborating Sponsors:
Arthrex GmbH
Conditions:
ACL Injury
Eligibility:
All Genders
18+ years
Brief Summary
Surgery using the Arthrex PEEK or Biocomposite FastThread Interference Screw for ACL or PCL (PCL at US sites only, Biocomposite screw PCL only) repair or reconstruction.
Detailed Description
The objective of the study is to evaluate the continued safety and effectiveness of the PEEK and Biocomposite FastThread Interference Screws used for Anterior Cruciate Ligament (ACL) and Posterior Cru...
Eligibility Criteria
Inclusion
- Subject requires surgery using the Arthrex PEEK Interference Screw for ACL or PCL (PCL at US sites only) repair or reconstruction or the Arthrex Biocomposite Interference Screw for PCL (PCL at US sites only) repair or reconstruction.
- Subject is 18 years of age or over.
- Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
- Subject signed informed consent and is willing and able to comply with all study requirements.
Exclusion
- Current bilateral injury of the ACL or PCL.
- Injury of the ACL and PCL in the same knee.
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections which may retard healing.
- Foreign-body sensitivity.
- Any active infection or blood supply limitations.
- Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- Subjects that are skeletally immature.
Key Trial Info
Start Date :
August 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04689061
Start Date
August 31 2020
End Date
August 1 2023
Last Update
February 16 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Anderson Sports Medicine
Bingham Farms, Michigan, United States, 48025
2
Sportklinik Ravensburg
Ravensburg, Germany, 88214