Osteoarthritis of Multiple Joints of Ankle or FootNCT02831244
Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
A study testing Agili-CTM in people with Osteoarthritis of Multiple Joints of Ankle or Foot, run by Smith & Nephew, Inc. at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of Multiple Joints of Ankle or Foot
- What is being tested?
- Agili-CTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 10 Aug 2016to 23 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.
Read the 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.
- Being tested
- Agili-CTM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agili-CTMDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Agili-CTM | Other | Intervention Receives: Device: Agili-CTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Ability Measure (FAAM) score
FAAM score will be evaluated at 24 months compared to baseline
Measured: 24 month
Visual Analog Scale (VAS) Pain
VAS will be evaluated at 24 months compared to baseline
Measured: 24 month
Secondary outcomes (6)
Great toe range of motion
Great toe range of motion will be evaluated at 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months compared to baseline
Measured: 2 weeks, 6 weeks, 3, 6, 12 18 and 24 months
Pain according to Visual Analog Scale (VAS)
VAS score will be evaluated at 2 weeks, 6 weeks, 3, 6, 12 and 18 months
Measured: 2 weeks, 6 weeks, 3, 6, 12 and 18 months
Activities of Daily Living Subscale according to Foot and Ankle Ability Measure (FAAM)
FAAM score will be evaluated at 2 weeks, 6 weeks, 3, 6, 12 and 18 months
Measured: 2 weeks, 6 weeks, 3, 6, 12 and 18 months
AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society-AOFAS)
AOFAS will be evaluated at 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months compared to baseline
Measured: 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months
Measurament of Joint Space maintenance in mm
Joint Space maintenance will be evaluated at 12, and 24 months compared to baseline
Measured: 12 and 24 months
Quality of life questionnaire (SF-36)
SF-36 will be evaluated at 6,12, 18 and 24 months compared to baseline
Measured: 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start10 Aug 2016
- Primary completion23 Jun 2019
- Study completion23 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of Multiple Joints of Ankle or FootStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831244
- Sponsor's protocol ID
- CLN0023
- Status last verified
- Feb 2020
- First submitted
- 29 Jun 2016
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Drobnic M, Vannini F, Kon E, Dulic O, Kecojevic V, Andor B, Altschuler N, Robinson D. Treatment of hallux rigidus by a novel bi-phasic aragonite-based implant: results of a two year multi-centre clinical trial. Int Orthop. 2021 Apr;45(4):1033-1041. doi: 10.1007/s00264-020-04872-8. Epub 2020 Nov 12.
PubMed 33184685
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
- ClinicalTrials.gov ID
- NCT02831244
- Acronym / sponsor ID
- CLN0023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 23 Jun 2019 (actual)
- Study completion
- 23 Jun 2019 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Agili-CTM | Other | Device: Agili-CTMIntervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agili-CTMConsenting 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 | Device | Agili-CTM |
Primary outcome
Foot and Ankle Ability Measure (FAAM) score
Time frame: 24 month
FAAM score will be evaluated at 24 months compared to baseline
Visual Analog Scale (VAS) Pain
Time frame: 24 month
VAS will be evaluated at 24 months compared to baseline
6 secondary outcomes
Great toe range of motion
Time frame: 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
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
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
Measurament of Joint Space maintenance in mm
Time frame: 12 and 24 months
Quality of life questionnaire (SF-36)
Time frame: 6, 12, 18 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 33184685Drobnic M, Vannini F, Kon E, Dulic O, Kecojevic V, Andor B, Altschuler N, Robinson D. Treatment of hallux rigidus by a novel bi-phasic aragonite-based implant: results of a two year multi-centre clinical trial. Int Orthop. 2021 Apr;45(4):1033-1041. doi: 10.1007/s00264-020-04872-8. Epub 2020 Nov 12.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agili-CTM in people with Osteoarthritis of Multiple Joints of Ankle or Foot, run by Smith & Nephew, Inc. at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, Italy, Serbia, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Ability Measure (FAAM) score (time frame: 24 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02831244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.