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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Agili-CTM | Other | Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Agili-CTM | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) score | FAAM score will be evaluated at 24 months compared to baseline | 24 month |
| Visual Analog Scale (VAS) Pain | VAS will be evaluated at 24 months compared to baseline | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks, 6 weeks, 3, 6, 12 18 and 24 months |
| Pain according to Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasharon Medical Center | Petah Tikva | Israel | ||||
| Rizzoli Orthopedic Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33184685 | Derived | Drobnic M, Vannini F, Kon E, Dulic O, Kecojevic V, Andor B, Altschuler N, Robinson D. Treatment of hallux rigidus by a novel bi-phasic aragonite-based implant: results of a two year multi-centre clinical trial. Int Orthop. 2021 Apr;45(4):1033-1041. doi: 10.1007/s00264-020-04872-8. Epub 2020 Nov 12. |
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VAS score will be evaluated at 2 weeks, 6 weeks, 3, 6, 12 and 18 months
| 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 | 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 | 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 | 12 and 24 months |
| Quality of life questionnaire (SF-36) | SF-36 will be evaluated at 6,12, 18 and 24 months compared to baseline | 6, 12, 18 and 24 months |
| Bologna |
| Italy |
| Clinical Center of Vojvodina | Novi Sad | Serbia |
| University Medical Centre | Ljubljana | Slovenia |