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

August 25, 2021 updated by: Cartiheal (2009) Ltd
The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah tikva, Israel
        • Hasharon Medical Center
  • Italy
      • Bologna, Italy
        • Rizzoli Orthopedic Institute
  • Serbia
      • Novi Sad, Serbia
        • Clinical Center of Vojvodina
  • Slovenia
      • Ljubljana, Slovenia
        • University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot and Ankle Ability Measure (FAAM) score
Time Frame: 24 month
FAAM score will be evaluated at 24 months compared to baseline
24 month
Visual Analog Scale (VAS) Pain
Time Frame: 24 month
VAS will be evaluated at 24 months compared to baseline
24 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks, 6 weeks, 3, 6, 12 18 and 24 months
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
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
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
2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months
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
12 and 24 months
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
6, 12, 18 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cartiheal (2009) Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2016

Primary Completion (Actual)

June 23, 2019

Study Completion (Actual)

June 23, 2019

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN0023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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