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FastThread Interference Screws

Sponsor
Arthrex, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04689061
Collaborator
Arthrex GmbH (Industry)
50
Enrollment
2
Locations
35
Anticipated Duration (Months)
25
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Arthrex FastThread Interference Screw

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Multi-Center, Prospective Study to Evaluate the Continued Safety and Effectiveness of the FastThread Interference Screws
Actual Study Start Date :
Aug 31, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. To assess change in Visual Analogue Scale (VAS) [preoperatively, 3 months, 6 months and 12 months post operative]

    Patient reported pain scale 0-10 point scale (0 min, 10 max)

  2. To assess change in Knee Injury and Osteoarthritis Outcome Score (KOOS) [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)

  3. To assess change in Range of Motion (ROM) [preoperatively, 3 months, 6 months and 12 months post operative]

    Measuring knee functionality. (Flexion 0 to 130 degrees Extension 120 to 0 degrees

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anderson Sports Medicine Bingham Farms Michigan United States 48025
2 Sportklinik Ravensburg Ravensburg Germany 88214

Sponsors and Collaborators

  • Arthrex, Inc.
  • Arthrex GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arthrex, Inc.
ClinicalTrials.gov Identifier:
NCT04689061
Other Study ID Numbers:
  • AIRR-0011
First Posted:
Dec 30, 2020
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Feb 16, 2022