Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.
The study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.Eligible patients with a large lesion will be treated with microfracture plus the Chondro-Gide® ACC and compared to patients with small lesions that are treated with microfracture alone. Outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.
Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells, followed by affixing Chondro-Gide® with fibrin glue.
The MORE Foundation
Phoenix, Arizona, United States
Orthopaedic Foundation
Stamford, Connecticut, United States
Emory Sports Medicine Complex
Johns Creek, Georgia, United States
Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS
The CCS is defined as a patient meeting all of the three following criteria: 1. Improvement in the Pain sub-scale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) between baseline to 24 months follow-up 2. Improvement in function, defined as an improvement in the International Knee Documentation Committee (IKDC) score between baseline to 24 months follow-up 3. Freedom from device- or procedure-related serious adverse events (SAEs) or secondary surgical intervention related to the device, procedure, or treated lesion
Time frame: 24 Months
Knee Injury and Osteoarthritis Outcome Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. Calculate the mean score of the individual items of each subscale and divide by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Magnetic Resonance Observation of Cartilage Score
Magnetic Resonance Image (MRI) will be obtain during the course of the study at 3 months and 24 months. MOCART 2.0 scoring will occur by independent assessment using the MOCART score. The score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score.
Time frame: 3 months, 24 months
Patient satisfaction
1. Were you satisfied with the procedure? (Satisfied, Somewhat satisfied, Neutral, Somewhat unsatisfied, Unsatisfied) 2. Would you have this procedure again if needed on the other knee? (Definitely yes, Probably yes, Not Sure, Probably Not, Definitely Not)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fraser Orthopaedic Institute
New Westminster, British Columbia, Canada
University of Calgary
Calgary, CGY, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Sunnybrook Research Institute (SRI)
Toronto, Ontario, Canada
University of Toronto Orthopaedics
Toronto, TOR, Canada
Gelenkzentrum Mittelrhein GmbH
Mayen, Mayen, Germany
...and 5 more locations
Time frame: 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Tegner Activity Scale
The Tegner activity score is a one-item score that grades activity based on work and sports activities. Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. A scale of the highest level activity being 10 and the lowest being 0
Time frame: 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Employment status
Employment status will be collected as: Employed full-time, Employed part-time, Not employed due to knee problems, Not employed due to reasons other than knee problems.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
EuroQol-5 Dimension (EQ-5D)
The EQ-5D measures as a descriptive system comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months