Smith & Nephew's European Trufit Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01246635
First received: November 14, 2010
Last updated: June 10, 2014
Last verified: June 2014

November 14, 2010
June 10, 2014
March 2008
November 2011   (final data collection date for primary outcome measure)
Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
Percent change in the KOOS Knee Survey Score from baseline [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01246635 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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-procdure ] [ Designated as safety issue: No ]
    Evaluation of cartilage at 24 months post-procedure will only occur for subjects who consent to a second-look biopsy.
  • Histological evaluation of cartilage [ Time Frame: 24 months post-procedure ] [ Designated as safety issue: No ]
    Histological characterization of cartilage will only occur for those subjects consenting to both the second look arthroscopy and biopsy at 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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)

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Defect of Articular Cartilage
  • 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
  • Experimental: TRUFIT CB with accelerated rehab.
    Intervention: Device: Trufit CB (Cartilage Bone) Implant
  • Experimental: TRUFIT CB with standard rehab.
    Intervention: Device: Trufit CB (Cartilage Bone) Implant
  • Active Comparator: • Microfracture with rehabilitation
    Intervention: Procedure: Microfracture if the knee
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
153
June 2014
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   Germany,   Ireland,   Netherlands,   Norway,   Sweden,   United Kingdom
 
NCT01246635
CSA-2005-02
Yes
Smith & Nephew, Inc.
Smith & Nephew, Inc.
Not Provided
Not Provided
Smith & Nephew, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP