The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.
Agili-C™ implant is a CE marked. The Agili-CTM implant is a 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
20
Consenting individuals will be selected from the population of patients with osteoarthritis of the great toe examined by a participating investigator. Following signing an informed consent, candidates will be evaluated by an adjudication committee for possible inclusion in the trial based on medical history and Standing Foot X-ray. Candidates that are approved or conditionally approved by the adjudication committee will undergo Agili-CTM implantation procedure
Hasharon Medical Center
Petah Tikva, Israel
Rizzoli Orthopedic Institute
Bologna, Italy
Clinical Center of Vojvodina
Novi Sad, Serbia
University Medical Centre
Ljubljana, Slovenia
Foot and Ankle Ability Measure (FAAM) score
FAAM score will be evaluated at 24 months compared to baseline
Time frame: 24 month
Visual Analog Scale (VAS) Pain
VAS will be evaluated at 24 months compared to baseline
Time frame: 24 month
Great toe range of motion
Great toe range of motion will be evaluated at 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months compared to baseline
Time frame: 2 weeks, 6 weeks, 3, 6, 12 18 and 24 months
Pain according to Visual Analog Scale (VAS)
VAS score will be evaluated at 2 weeks, 6 weeks, 3, 6, 12 and 18 months
Time frame: 2 weeks, 6 weeks, 3, 6, 12 and 18 months
Activities of Daily Living Subscale according to Foot and Ankle Ability Measure (FAAM)
FAAM score will be evaluated at 2 weeks, 6 weeks, 3, 6, 12 and 18 months
Time frame: 2 weeks, 6 weeks, 3, 6, 12 and 18 months
AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society-AOFAS)
AOFAS will be evaluated at 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months compared to baseline
Time frame: 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months
Measurament of Joint Space maintenance in mm
Joint Space maintenance will be evaluated at 12, and 24 months compared to baseline
Time frame: 12 and 24 months
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Quality of life questionnaire (SF-36)
SF-36 will be evaluated at 6,12, 18 and 24 months compared to baseline
Time frame: 6, 12, 18 and 24 months