Status:
ACTIVE_NOT_RECRUITING
Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Focal Cartilage Lesions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Lesions in the cartilage are common disorders. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for tre...
Detailed Description
Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority are found in the ...
Eligibility Criteria
Inclusion
- Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible
- Minimal age of 18 years old (Preferred age group \>40 years)
- Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion. The maximum size of the lesion is set at 6cm².
- Informed consent obtained
Exclusion
- Active or recent (\<1 yr) septic arthritis of the involved knee
- Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee
- (Severe) osteoarthritis in the involved or other compartments of the involved knee
- Severe osteoporosis
- MRI not possible (eg. due to pacemaker)
- Marked valgus- or varus alignment (\>6 degrees)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04808700
Start Date
January 1 2015
End Date
December 1 2028
Last Update
November 8 2024
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000