ACL Injury
Conditions
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.
Interventions
DEVICEArthrex 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
Sponsors
Arthrex GmbH
Arthrex, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess change in Visual Analogue Scale (VAS) | preoperatively, 3 months, 6 months and 12 months post operative | Patient reported pain scale 0-10 point scale (0 min, 10 max) |
| To assess change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | preoperatively, 3 months, 6 months and 12 months post operative | Patient reported outcome assessment. The interval score ranges from 0 to 100, (where 0 represents total knee disability and 100 represents perfect knee health) |
| To assess change in Range of Motion (ROM) | preoperatively, 3 months, 6 months and 12 months post operative | Measuring knee functionality. (Flexion 0 to 130 degrees Extension 120 to 0 degrees |
Countries
Germany, United States
Contacts
Primary ContactSamantha Martino
Outcome results
None listed