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Completed

NCT Number: NCT02831244

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

The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.

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Key information

Conditions

Osteoarthritis of Multiple Joints of Ankle or Foot

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasharon Medical Center, Petah Tikva, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 13, 2016
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.