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

Osteoarthritis of Multiple Joints of Ankle or Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831244
• Other study ID #: CLN0023
• Status: Completed
• Phase: N/A
• Start date: August 10, 2016
• Est. completion date: June 23, 2019

Study information

• Verified date: February 2020
• Source: Cartiheal (2009) Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 23, 2019
• Est. primary completion date: June 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Multiple Joints of Ankle or Foot

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

Locations

Country	Name	City	State
Israel	Hasharon Medical Center	Petah tikva
Italy	Rizzoli Orthopedic Institute	Bologna
Serbia	Clinical Center of Vojvodina	Novi Sad
Slovenia	University Medical Centre	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Cartiheal (2009) Ltd

Countries where clinical trial is conducted

Israel,  Italy,  Serbia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot and Ankle Ability Measure (FAAM) score	FAAM score will be evaluated at 24 months compared to baseline	24 month
Primary	Visual Analog Scale (VAS) Pain	VAS will be evaluated at 24 months compared to baseline	24 month
Secondary	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	2 weeks, 6 weeks, 3, 6, 12 18 and 24 months
Secondary	Pain according to Visual Analog Scale (VAS)	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
Secondary	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	2 weeks, 6 weeks, 3, 6, 12 and 18 months
Secondary	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	2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months
Secondary	Measurament of Joint Space maintenance in mm	Joint Space maintenance will be evaluated at 12, and 24 months compared to baseline	12 and 24 months
Secondary	Quality of life questionnaire (SF-36)	SF-36 will be evaluated at 6,12, 18 and 24 months compared to baseline	6, 12, 18 and 24 months