Cartilage Disease, Cartilage Injury, Knee Discomfort, Knee Injuries
Conditions
Keywords
Microfracture, Cartilage, Knee
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMicrofracture
Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.
DEVICEMicrofracture plus placement of Chondro-Gide® ACC
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.
Sponsors
Geistlich Pharma AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent 2. One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy 3. Between 18 and 55 years of age 4. Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol
Exclusion criteria
1. BMI ≥ 30 kg/m2 2. Symptomatic contralateral knee 3. Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more 4. Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment) 5. Patella dysplasia 6. Chronic inflammatory arthritis or infectious arthritis 7. History of autoimmune disease or immunodeficiency 8. History of connective tissue disease 9. Intra-articular steroid use within the 3 months prior to enrollment 10. Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment 11. The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone 12. Pregnancy or lack of adequate contraceptives if a female of child-bearing potential 13. Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study 14. Active infection of the index knee 15. Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan 16. Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions 17. History or current substance or alcohol abuse as defined by the DSM-V 18. Any other medical condition that the investigator determines would interfere with the validity of the study 19. Known allergy to porcine collagen 20. Symptom duration greater than 36 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS | 24 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score | Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 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. |
| Magnetic Resonance Observation of Cartilage Score | 3 months, 24 months | 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. |
| Patient satisfaction | 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 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) |
| Tegner Activity Scale | 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 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 |
| Employment status | Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 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. |
| EuroQol-5 Dimension (EQ-5D) | Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 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. |
Countries
Canada, Germany, United States
Contacts
STUDY_DIRECTORFabiana Martinelli
Geistlich Pharma AG
PRINCIPAL_INVESTIGATORKevin Plancher, MD
Plancher Orthopedics and Sports Medicine
Outcome results
None listed