Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.
Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects. The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
143
Candidates for Agili-C™ implantation will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.
Medical University of Vienna
Vienna, Austria
AZ Monica
Antwerp, Belgium
Hasharon medical center
Petah Tikva, Israel
Rizzoli Orthopaedic Institute
Bologna, Italy
• The KOOS Pain Subscale relative to baseline
The KOOS pain subscale is evaluated at 6m, 12m, 18m \& 24m
Time frame: 24 Months
• Improvement in other KOOS subscales relative to baseline
Other KOOS subscales are evaluated at 6m, 12m, 18m \& 24m
Time frame: 24 Months
• Improvement in IKDC Subjective Knee Score relative to baseline
IKDC Subjective Knee Score is evaluated at 6m, 12m, 18m \& 24m
Time frame: 24 Months
• Improvement in SF-36 Survey
SF-36 Survey is evaluated at 6m, 12m, 18m \& 24m
Time frame: 24 Months
• Improvement in Tegner Score
Tegner Score is evaluated at 6m, 12m, 18m \& 24m
Time frame: 24 Months
• Improvement in Lysholm Knee Scoring Scale
Lysholm Knee Scoring Scale is evaluated at 6m, 12m, 18m \& 24m
Time frame: 24 Months
• Joint Space maintenance rate according to X-ray
Joint Space maintenance rate is evaluated at 12m \& 24m
Time frame: 24 Months
• Defect Fill according to MRI
Defect Fill according to MRI is evaluated at 6m, 12m, 18m \& 24m
Time frame: 24 Months
Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Specialist Hospital. Louis Rydygier
Krakow, Poland
Timişoara County Hospital
Timișoara, Romania
Institut za Ortopedsko-hirurške Bolesti "banjica"
Belgrade, Serbia
University Medical Centre Ljubljana
Ljubljana, Slovenia
The KOOS Overall is evaluated at 6, 12,18 \& 24 months
Time frame: 24 mMonths