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Smith & Nephew's European Trufit Study

NCT01246635 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2021-04-01

No results posted yet for this study

Summary

The purpose of this clinical study is to demonstrate the effectiveness and safety of the Trufit CB (Cartilage Bone) implant for the treatment of single, isolated cartilage defects of the knee compared to Microfracture.

Conditions

  • Defect of Articular Cartilage

Interventions

DEVICE

Trufit CB (Cartilage Bone) Implant

Implantation of 5,7, 9, or 11 mm Trufit CB Implants for small cartilage lesions. A maximum of two Trufit CB plugs may be implanted.

PROCEDURE

Microfracture if the knee

Creation of small holes through subchondral bone with the goal of stimulating cartilage growth

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-15
Primary Completion
2011-11-30
Completion
2014-12-31

Countries

  • Belgium
  • Denmark
  • Germany
  • Ireland
  • Netherlands
  • Norway
  • Sweden
  • 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 NCT01246635 on ClinicalTrials.gov