Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2020-08-31
2023-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Arthrex GmbH
INDUSTRY
Arthrex, Inc.
INDUSTRY
Responsible Party
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Locations
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Anderson Sports Medicine
Bingham Farms, Michigan, United States
Sportklinik Ravensburg
Ravensburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AIRR-0011
Identifier Type: -
Identifier Source: org_study_id
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