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FibroFix Cartilage P Knee Implant Study

NCT05560490 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-07-24

No results posted yet for this study

Summary

This is a multi-center first-in-human prospective clinical investigation to evaluate the safety and performance of the FibroFix™ Cartilage P Implant and Drill Set. The Implant is a medical device designed by Orthox Ltd. to repair a damaged area of cartilage within the knee joint.

The aim is to 75 participants over two Stages:

In STAGE I, up to a total of 6 subjects will be recruited and safety assessed after 6 months of follow-up.

In Stage II an additional 69 subjects. The subjects will be followed up for 2 years with MRI imaging, then a further 8 years with patient outcome questionnaires.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

FibroFix Cartilage P Knee Implantation

The FibroFix Cartilage P instrument set (Drill set) is used for the preparation of an implant site and placement of the FibroFix Cartilage P Implant to resurface an articular cartilage lesion in the anterior and central regions of the femoral condyles of the knee.

Sponsors & Collaborators

  • Avania B.V.

    collaborator UNKNOWN

  • Orthox Limited

    lead INDUSTRY

Principal Investigators

  • Michael Whitehouse · North Bristol NHS HospitalsTrust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2023-07-07
Completion
2023-07-07

Countries

  • Hungary
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560490 on ClinicalTrials.gov