FastThread Interference Screws

Last updated: February 15, 2022
Sponsor: Arthrex, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04689061
AIRR-0011
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject requires surgery using the Arthrex PEEK Interference Screw for ACL or PCL (PCLat US sites only) repair or reconstruction or the Arthrex Biocomposite InterferenceScrew 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 studyrequirements.

Exclusion

Exclusion Criteria:

  • 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 restrictactivities or follow directions during the healing period.
  • Subjects that are skeletally immature.

Study Design

Total Participants: 50
Study Start date:
August 31, 2020
Estimated Completion Date:
August 31, 2023

Study 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 Cruciate Ligament (PCL) repair or reconstruction (PCL at US sites only, Biocomposite screw PCL only).

To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate effectiveness, patient reported outcomes will be collected at 3 months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS) for measuring pain in the affected knee and the Knee Injury and Osteoarthritis Outcome Score (KOOS) as well as Range of Motion (ROM, optional) for measuring knee functionality.

Connect with a study center

  • Sportklinik Ravensburg

    Ravensburg, 88214
    Germany

    Active - Recruiting

  • Anderson Sports Medicine

    Bingham Farms, Michigan 48025
    United States

    Active - Recruiting

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