Smith & Nephew's European Trufit Study

March 19, 2021 updated by: Smith & Nephew, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Karl Brabants, MD
      • Ghent, Belgium
        • Prof. Dr. K.F. Almqvist
      • Herentals, Belgium
        • Toon Claes, MD
      • Leuven, Belgium
        • Johan Vanlauwe
  • Denmark
      • Aalborg, Denmark
        • Aalborg Private Hospital A/S
  • Germany
      • Hamburg, Germany
        • Johannes Holz, MD
  • Ireland
      • Dublin, Ireland
        • Kevin J. Mulhall
  • Netherlands
      • Nijmegen, Netherlands
        • Sander Koeter, MD
      • Zwolle, Netherlands
        • Kees van Egmond, MD
  • Norway
      • Oslo, Norway
        • Lars Engebretsen, MD
  • Sweden
      • Stockholm, Sweden
        • Magnus Forssblad, MD
  • United Kingdom
      • Cardiff, United Kingdom
        • Angus Robertson, MD
      • Coventry, United Kingdom
        • Tim Spalding, MD
      • Fife Keith, United Kingdom
        • David Chesney

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Capable of providing informed consent;
  • Eighteen (18) years or older and skeletally mature on the date of study enrollment;
  • Willing and able to attend all follow up visits and complete all study related procedures and evaluations including, but not limited to adhering to the rehabilitation protocol;
  • Single, isolated cartilage defect (ICRS Grade III - IV) in the knee (medial or lateral femoral condyle or trochlea) that is ≥ 1cm2 (10 mm) and ≤ 2cm2 (20 mm) in area and requiring a maximum of 2 implants (if randomized to TRUFIT CB); Note: Lesion size should be assessed as the product of the longest diameter and its perpendicular applied at the widest portion of the lesion.
  • Candidate for cartilage repair surgery as a result of a single, isolated symptomatic cartilage lesion;
  • Presents with stable health at the time of study enrollment;
  • BMI of ≤ 32.

Exclusion Criteria:

  • Female of child-bearing potential who is pregnant or plans to become pregnant over the course of the study;
  • History of alcohol or drug abuse;
  • Presents with patellofemoral instability or other anatomical malalignment in the study knee;
  • Any diagnosis that would preclude the patient from successfully completing the study rehabilitation protocols;
  • Unable or unwilling to follow post operative procedures (e.g. rehabilitation protocol);
  • Received one or more intra-articular steroid injections in the study knee within the previous 3 months;
  • Presents with ipsilateral hip disease, as determined by pain or restricted range of motion upon physical examination;
  • Treated with either an investigational device or drug within one (1) month of study enrollment, or plans to be treated with an investigational device or drug in the next 24 months;
  • Diagnosed rheumatoid arthritis, ankylosing spondylitis (Bechterew syndrome), or calcium pyrophosphate dihydrate disease(chondrocalcinosis);
  • History of severe vascular or neurological disease, uncontrolled diabetes, or is immunosuppressed (e.g. HIV positive);
  • Musculoskeletal disease, including degenerative bone diseases such as osteochondritis dissecans and osteonecrosis;
  • Pathologic conditions of the bone (e.g. osteoporosis, cystic changes, hyperparathyroidism, Paget's Disease, hypercalcemia, prolonged use of steroids);
  • Active infection, or evidence thereof, at the lesion site;
  • Requires the use of any medication(s) or treatment(s) known to have an effect on bone metabolism (e.g. bisphosphonates, chemotherapeutic or immunosuppressive agents);
  • Requires concomitant osteotomy, partial lateral meniscectomy or complete meniscectomy; Note: Concomitant ACL reconstruction or revision, as well as meniscal repair and partial medial meniscectomies are permitted under the study protocol.
  • Has undergone an ACL reconstruction, osteotomy, chondral resurfacing procedure or partial meniscectomy (≤ central third of the meniscus) in the last year and has not completed at least 6 months of rehabilitation since such surgery; Note: Patients who have undergone these procedures within the last year and have completed at least 6 months of rehabilitation are eligible to participate in the study.
  • Any active, implanted medical device (e.g. cochlear implant) or metallic implant (other then dental work) that may interfere with Magnetic Resonance Imaging (MRI);
  • Any condition (e.g. claustrophobia) that may interfere with the patient's ability to undergo MRI;
  • Diagnosis requiring placement of an active implant (e.g. cardiac pacemaker, vagus nerve stimulator, etc.) within the next 24 months.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TRUFIT CB with accelerated rehab.
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.
Experimental: TRUFIT CB with standard rehab.
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.
Active Comparator: • Microfracture with rehabilitation
Procedure: Microfracture if the knee
Creation of small holes through subchondral bone with the goal of stimulating cartilage growth

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline
Time Frame: 6 months post-procedure
6 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent improvement from baseline in the KOOS Knee Survey Score at all time-points
Time Frame: 2 weeks, 6, weeks, 3 months, (6 months - primary measure), 12 months and 24 months post-procedure
2 weeks, 6, weeks, 3 months, (6 months - primary measure), 12 months and 24 months post-procedure
Positive change in activity level from baseline to each visit, as measured by the Tegner Activity Scale at all time-points.
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
Difference in Pain Scores on the Visual Analog Scale from baseline at all post operative time-points.
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
Magnetic resonance evaluation of cartilage and underlying bone using the MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scale
Time Frame: 12 and 24 months post-procedure
12 and 24 months post-procedure
Proportion of subjects (compared to baseline) with cartilage classifications within the four groups defined by the International Cartilage Repair Society (ICRS) scoring system
Time Frame: 24 months post-procedure
Evaluation of cartilage at 24 months post-procedure will only occur for subjects who consent to a second-look biopsy.
24 months post-procedure
Histological evaluation of cartilage
Time Frame: 24 months post-procedure
Histological characterization of cartilage will only occur for those subjects consenting to both the second look arthroscopy and biopsy at 24-months post-procedure.
24 months post-procedure
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smith & Nephew, Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSA-2005-02

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings