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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
153
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.
Creation of small holes through subchondral bone with the goal of stimulating cartilage growth
Karl Brabants, MD
Antwerp, Belgium
Prof. Dr. K.F. Almqvist
Ghent, Belgium
Toon Claes, MD
Herentals, Belgium
Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline
Time frame: 6 months post-procedure
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
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
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
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
Proportion of subjects (compared to baseline) with cartilage classifications within the four groups defined by the International Cartilage Repair Society (ICRS) scoring system
Evaluation of cartilage at 24 months post-procedure will only occur for subjects who consent to a second-look biopsy.
Time frame: 24 months post-procedure
Histological evaluation of cartilage
Histological characterization of cartilage will only occur for those subjects consenting to both the second look arthroscopy and biopsy at 24-months post-procedure.
Time frame: 24 months post-procedure
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Johan Vanlauwe
Leuven, Belgium
Aalborg Private Hospital A/S
Aalborg, Denmark
Johannes Holz, MD
Hamburg, Germany
Kevin J. Mulhall
Dublin, Ireland
Sander Koeter, MD
Nijmegen, Netherlands
Kees van Egmond, MD
Zwolle, Netherlands
Lars Engebretsen, MD
Oslo, Norway
...and 4 more locations
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