NCT01246635

Smith & Nephew's European Trufit Study

A Prospective, Multi-Center, Randomized, Single-Blind, Controlled Study Comparing the Trufit CB (Cartilage Bone) Implant to Microfracture for the Treatment of Patients With Single, Isolated Defects of the Knee

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Up to 315 subjects, ages 18 years and older with a single, isolated cartilage defect of the knee will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups: * Trufit CB Implant with rehabilitation protocol; * Trufit CB Implant with rehabilitation protocol; * Microfracture with rehabilitation protocol Rehabilitation program may be standard (6 weeks touch weight to full weight bearing) or accelerated (2 weeks touch weight to full weight bearing).

Conditions

• Defect of Articular Cartilage

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-04-15
• Primary completion: 2011-11-01
• Completion: 2014-12-01
• First posted: 2010-11-23
• Last updated: 2021-04-01

Locations

14 sites across 8 countries: Belgium, Denmark, Germany, Ireland, Netherlands, Norway, Sweden, United Kingdom