Clinical trial NCT04689061: FastThread Interference Screws
Official title: A Multi-Center, Prospective Study to Evaluate the Continued Safety and Effectiveness of the FastThread Interference Screws
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ACL Injury
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Arthrex GmbH
First posted: 2020-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 50 subjects, male and female, at least 18 years of age, will be enrolled for the study. Subjects will be recruited from the surgeon's patient population or referrals from other physicians. The enrollment period is estimated to be 12 months.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess change in Visual Analogue Scale (VAS)
timeFrame: preoperatively, 3 months, 6 months and 12 months post operative
measure: To assess change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: preoperatively, 3 months, 6 months and 12 months post operative
measure: To assess change in Range of Motion (ROM)
timeFrame: preoperatively, 3 months, 6 months and 12 months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Bingham Farms
country: United States
facility: Anderson Sports Medicine
state: Michigan
city: Ravensburg
country: Germany
facility: Sportklinik Ravensburg
Study officials:
References: