FastThread Interference Screws
A Multi-Center, Prospective Study to Evaluate the Continued Safety and Effectiveness of the FastThread Interference Screws
1 other identifier
observational
50
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2020
CompletedFirst Submitted
Initial submission to the registry
December 23, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFebruary 16, 2022
February 1, 2022
2.4 years
December 23, 2020
February 15, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
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
Interventions
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
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arthrex, Inc.lead
- Arthrex GmbHcollaborator
Study Sites (2)
Anderson Sports Medicine
Bingham Farms, Michigan, 48025, United States
Sportklinik Ravensburg
Ravensburg, 88214, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2020
First Posted
December 30, 2020
Study Start
August 31, 2020
Primary Completion
February 1, 2023
Study Completion
August 1, 2023
Last Updated
February 16, 2022
Record last verified: 2022-02