NCT02831244

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

August 10, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2019

Completed
Last Updated

March 6, 2025

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

June 29, 2016

Last Update Submit

March 3, 2025

Conditions

Osteoarthritis of Multiple Joints of Ankle or Foot

Outcome Measures

Primary Outcomes (2)

  • Foot and Ankle Ability Measure (FAAM) score

    FAAM score will be evaluated at 24 months compared to baseline

    24 month

  • Visual Analog Scale (VAS) Pain

    VAS will be evaluated at 24 months compared to baseline

    24 month

Secondary Outcomes (6)

  • Great toe range of motion

    2 weeks, 6 weeks, 3, 6, 12 18 and 24 months

  • Pain according to Visual Analog Scale (VAS)

    2 weeks, 6 weeks, 3, 6, 12 and 18 months

  • Activities of Daily Living Subscale according to Foot and Ankle Ability Measure (FAAM)

    2 weeks, 6 weeks, 3, 6, 12 and 18 months

  • AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society-AOFAS)

    2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months

  • Measurament of Joint Space maintenance in mm

    12 and 24 months

  • +1 more secondary outcomes

Study Arms (1)

Agili-CTM

OTHER

Intervention

Device: Agili-CTM

Interventions

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

Agili-CTM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hasharon Medical Center

Petah Tikva, Israel

Location

Rizzoli Orthopedic Institute

Bologna, Italy

Location

Clinical Center of Vojvodina

Novi Sad, Serbia

Location

University Medical Centre

Ljubljana, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 33184685DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 13, 2016

Study Start

August 10, 2016

Primary Completion

June 23, 2019

Study Completion

June 23, 2019

Last Updated

March 6, 2025

Record last verified: 2020-02

Locations

SL(1)IT(1)SE(1)IL(1)