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| Name | Class |
|---|---|
| Arthrex GmbH | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrex FastThread Interference Screw | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess change in Visual Analogue Scale (VAS) | Patient reported pain scale 0-10 point scale (0 min, 10 max) | preoperatively, 3 months, 6 months and 12 months post operative |
| To assess change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome assessment. The interval score ranges from 0 to 100, (where 0 represents total knee disability and 100 represents perfect knee health) | preoperatively, 3 months, 6 months and 12 months post operative |
| To assess change in Range of Motion (ROM) | Measuring knee functionality. (Flexion 0 to 130 degrees Extension 120 to 0 degrees | preoperatively, 3 months, 6 months and 12 months post operative |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Martino | Contact | 800.933.7001 | 73506 | samantha.martino@arthrex.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anderson Sports Medicine | Recruiting | Bingham Farms | Michigan | 48025 | United States |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Sportklinik Ravensburg | Recruiting | Ravensburg | 88214 | Germany |
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