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Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Cartiheal (2009) Ltd

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Multiple Joints of Ankle or Foot Device: Agili-CTM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Agili-CTM
Intervention
Device: Agili-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




Primary Outcome Measures :
  1. Foot and Ankle Ability Measure (FAAM) score [ Time Frame: 24 month ]
    FAAM score will be evaluated at 24 months compared to baseline

  2. Visual Analog Scale (VAS) Pain [ Time Frame: 24 month ]
    VAS will be evaluated at 24 months compared to baseline


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Israel
Hasharon Hospital
Petah Tikva, Israel
Sponsors and Collaborators
Cartiheal (2009) Ltd

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Responsible Party: Cartiheal (2009) Ltd
ClinicalTrials.gov Identifier: NCT02831244    
Other Study ID Numbers: CLN0023
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases