Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
- Conditions
- Osteoarthritis of Multiple Joints of Ankle or Foot
- Interventions
- Device: Agili-CTM
- Registration Number
- NCT02831244
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 18 years or older
- Osteoarthritis of the First Metatarsophalangeal Joint
- Presence of good bone stock
- Physically and mentally willing and able to comply with post-operative
- rehabilitation and routinely scheduled clinical and radiographic visits
- < 18 years of age
- Any past or present evidence of infection of the treated joint
- Any known malignant tumor of the foot
- Known inflammatory arthropathy or crystal-deposition arthropathy
- Chemotherapy treatment in the past 12 months
- History of allergic reaction or intolerance to calcium carbonate or hyaluronate
- Patient who is pregnant or intends to become pregnant during the study
- History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
- Known substance abuse or alcohol abuse
- Participation in other clinical trials in parallel to this study
- Known insulin dependent diabetes mellitus
- Unable to undergo imaging studies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Agili-CTM Agili-CTM Intervention
- Primary Outcome Measures
Name Time Method Foot and Ankle Ability Measure (FAAM) score 24 month FAAM score will be evaluated at 24 months compared to baseline
Visual Analog Scale (VAS) Pain 24 month VAS will be evaluated at 24 months compared to baseline
- Secondary Outcome Measures
Name Time Method Great toe range of motion 2 weeks, 6 weeks, 3, 6, 12 18 and 24 months Great toe range of motion will be evaluated at 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months compared to baseline
Pain according to Visual Analog Scale (VAS) 2 weeks, 6 weeks, 3, 6, 12 and 18 months VAS score will be evaluated at 2 weeks, 6 weeks, 3, 6, 12 and 18 months
Activities of Daily Living Subscale according to Foot and Ankle Ability Measure (FAAM) 2 weeks, 6 weeks, 3, 6, 12 and 18 months FAAM score will be evaluated at 2 weeks, 6 weeks, 3, 6, 12 and 18 months
AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society-AOFAS) 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months AOFAS will be evaluated at 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months compared to baseline
Measurament of Joint Space maintenance in mm 12 and 24 months Joint Space maintenance will be evaluated at 12, and 24 months compared to baseline
Quality of life questionnaire (SF-36) 6, 12, 18 and 24 months SF-36 will be evaluated at 6,12, 18 and 24 months compared to baseline
Trial Locations
- Locations (4)
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
Rizzoli Orthopedic Institute
🇮🇹Bologna, Italy
Hasharon Medical Center
🇮🇱Petah tikva, Israel
University Medical Centre
🇸🇮Ljubljana, Slovenia