FastThread Interference Screws

February 15, 2022 updated by: Arthrex, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess change in Visual Analogue Scale (VAS)
Time Frame: preoperatively, 3 months, 6 months and 12 months post operative
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)
Time Frame: 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)
preoperatively, 3 months, 6 months and 12 months post operative
To assess change in Range of Motion (ROM)
Time Frame: preoperatively, 3 months, 6 months and 12 months post operative
Measuring knee functionality. (Flexion 0 to 130 degrees Extension 120 to 0 degrees
preoperatively, 3 months, 6 months and 12 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthrex, Inc.

Collaborators

Arthrex GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIRR-0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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