FastThread Interference Screws

Arthrex

Status: Unknown

Conditions: ACL Injury

Treatments: Device: Arthrex FastThread Interference Screw

Study type: Observational

Funder types: Industry

Identifiers

NCT04689061

AIRR-0011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Biocomposite FastThread Interference Screw

Description:

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

Treatment:

Device: Arthrex FastThread Interference Screw