Clinical trial NCT02831244: Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
Official title: Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Multiple Joints of Ankle or Foot
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Foot and Ankle Ability Measure (FAAM) score
timeFrame: 24 month
measure: Visual Analog Scale (VAS) Pain
timeFrame: 24 month
Secondary outcomes:
measure: Great toe range of motion
timeFrame: 2 weeks, 6 weeks, 3, 6, 12 18 and 24 months
measure: Pain according to Visual Analog Scale (VAS)
timeFrame: 2 weeks, 6 weeks, 3, 6, 12 and 18 months
measure: Activities of Daily Living Subscale according to Foot and Ankle Ability Measure (FAAM)
timeFrame: 2 weeks, 6 weeks, 3, 6, 12 and 18 months
measure: AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society-AOFAS)
timeFrame: 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months
measure: Measurament of Joint Space maintenance in mm
timeFrame: 12 and 24 months
measure: Quality of life questionnaire (SF-36)
timeFrame: 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Hasharon Medical Center
city: Bologna
country: Italy
facility: Rizzoli Orthopedic Institute
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Ljubljana
country: Slovenia
facility: University Medical Centre
Study officials:
References:
citation: 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.