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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-10

Study Completion Date

2019-06-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis of Multiple Joints of Ankle or Foot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Agili-CTM

Intervention

Group Type OTHER

Agili-CTM

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No