Recruiting

FastThread

Sponsor:

Arthrex, Inc.

Code:

NCT04689061

Conditions

ACL Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arthrex FastThread Interference Screw

Study Details

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.

Conditions

ACL Injury

Study ID

NCT04689061

Start date

Aug 31, 2020

Status verified date

Feb, 2022

Completion date

Aug, 2023

Anticipated

Primary completion date

Feb, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Biocomposite FastThread Interference Screw

The absorbable Biocomposite Interference Screws combine the inherent degradation characteristics of a biocompatible polymer with the bioactivity of a ceramic. They are made of a combination of 70% poly (L-lactide-co-D, L-lactide) (PLDLA) and 30% biphasic calcium phosphate (BCP). The material has withstood the test of time with over a decade of clinical use and millions of implantations. It has been shown that the Biocomposite Interference Screw integrates well into the surrounding bone, produces little to no inflammatory response, and partially degrades 2 years after implantation

Interventions

Arthrex FastThread Interference Screw

The Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping. The Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping

Primary outcome measure

  • To assess change in Visual Analogue Scale (VAS) [ Time Frame: preoperatively, 3 months, 6 months and 12 months post operative ]
  • To assess change in Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: preoperatively, 3 months, 6 months and 12 months post operative ]
  • To assess change in Range of Motion (ROM) [ Time Frame: preoperatively, 3 months, 6 months and 12 months post operative ]

Central Contacts and Locations

Central contacts

Samantha Martino

800.933.7001samantha.martino@arthrex.com

Locations

Anderson Sports Medicine

Recruiting

Bingham Farms, Michigan, United States, 48025

Contacts

Samantha Martino

800-933-7001samantha.martino@arthrex.com

More Information

Sponsor

Arthrex, Inc.

Last update posted

Feb 16, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arthrex, Inc. on 2022-02-16.