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
  Purpose

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.


Condition Intervention Phase
Defect of Articular Cartilage
Device: Trufit CB (Cartilage Bone) Implant
Procedure: Microfracture if the knee
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 153
Study Start Date: March 2008
Estimated Study Completion Date: June 2014
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246635

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

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01246635     History of Changes
Other Study ID Numbers: CSA-2005-02
Study First Received: November 14, 2010
Last Updated: June 10, 2014
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Cartilage Diseases
Connective Tissue Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014