Osteoarthritis of Multiple Joints of Ankle or Foot
Conditions
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.
Interventions
DEVICEAgili-CTM
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
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* \< 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Israel, Italy, Serbia, Slovenia
Outcome results
None listed