Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
March 3, 2025 updated by: Smith & Nephew, Inc.
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
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.
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
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
|
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
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.
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 (Estimated)
July 13, 2016
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 3, 2025
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.