FastThread Interference Screws

ACL Injury Clinical Trial

Official title:

A Multi-Center, Prospective Study to Evaluate the Continued Safety and Effectiveness of the FastThread Interference Screws

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689061
• Other study ID #: AIRR-0011
• Status: Recruiting
• Start date: August 31, 2020
• Est. completion date: August 2023

Study information

• Verified date: February 2022
• Source: Arthrex, Inc.
• Contact: Samantha Martino
• Phone: 800.933.7001
• Email: samantha.martino[@]arthrex.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Device:
• 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

Locations

Country	Name	City	State
Germany	Sportklinik Ravensburg	Ravensburg
United States	Anderson Sports Medicine	Bingham Farms	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Arthrex, Inc.	Arthrex GmbH

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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