Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
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|ClinicalTrials.gov Identifier: NCT02831244|
Recruitment Status : Unknown
Verified December 2017 by Cartiheal (2009) Ltd.
Recruitment status was: Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of Multiple Joints of Ankle or Foot||Device: Agili-CTM||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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
- Foot and Ankle Ability Measure (FAAM) score [ Time Frame: 24 month ]FAAM score will be evaluated at 24 months compared to baseline
- Visual Analog Scale (VAS) Pain [ Time Frame: 24 month ]VAS will be evaluated at 24 months compared to baseline
- Great toe range of motion [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 12 and 24 months ]Joint Space maintenance will be evaluated at 12, and 24 months compared to baseline
- Quality of life questionnaire (SF-36) [ Time Frame: 6, 12, 18 and 24 months ]SF-36 will be evaluated at 6,12, 18 and 24 months compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831244
|Petah Tikva, Israel|