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AMIC vs. MFx in the Ankle (AMARTA)

Primary Purpose

Osteochondral Lesion of Talus, Chondral Defect, Microfracture

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Microfracture (MFx)
Chondro-Gide®
Sponsored by
Geistlich Pharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteochondral Lesion of Talus focused on measuring double-blind Randomised Controlled Trial (RCT), Chondro-Gide®, AMIC®

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Signed written informed consent Diagnosis of symptomatic osteochondral or chondral lesion of the talus, deemed by surgeon amenable to arthroscopic treatment with debridement and microfracture Age of 18-65 years Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, the rehabilitation protocol and responding to patient questionnaire follow up Exclusion criteria: Lesions smaller 1 square centimeters and greater than 4 square centimeters based on the MRI Malalignment which is not corrected prior to or as part of same surgery Established significant hindfoot arthritis Patients who are unable to have an MRI scan Chronic inflammatory arthritis or infectious arthritis History of autoimmune disease or immunodeficiency History of connective tissue disease Intra-articular steroid use within the 3 months prior to enrolment Other intra-articular injections (e.g., hyaluronic acid) within 3 months prior to enrolment The patient is currently being treated with radiation, chemotherapy, immunosuppression, or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone Pregnancy or lactation Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the clinical investigation Active infection of the index ankle Has been prescribed medication to treat osteoporosis Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions

Sites / Locations

  • Freeman HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AMIC®

Microfracture (MFx)

Arm Description

Bone Marrow Stimulation (Microfracture) with Chondro-Gide®

Microfracture alone

Outcomes

Primary Outcome Measures

Manchester Oxford Foot Questionnaire (MOX-FQ) walking/standing subscale
The effectiveness of the treatment is measured by the difference in the walking/standing- part score taken from the the MOX-FQ from baseline to 12 months. Raw score values for the walking/standing part are between 0-28, where higher score mean a worse outcome. Raw scores are converted to a metric (0-100).

Secondary Outcome Measures

Manchester Oxford Foot Questionnaire (MOX-FQ) total
The MOX-FQ is a commonly reported scoring system in the literature with proven acceptability, reliability and responsiveness for assessment of patients undergoing various foot and ankle surgeries. The total score consists of 3 subscales: Pain, Walking/ Standing and Social interaction. Raw score values for the total score are between 0-64, where higher score mean a worse outcome. Raw scores are converted to a metric (0-100).
American Orthopaedic Foot and Ankle-Hind foot Score (AOFAS)
The AOFAS has been used as a tool to measure the functional outcome after foot and ankle surgery and is often regarded as an essential outcome measure for all clinical studies. The score ranges from 0 - 100, where higher scores mean better outcomes.
Foot Functioning Index (FFI)
The FFI measures a patient's function in terms of pain, disability, and activity restriction to assess the impact of foot pathology. The index is self-administered and consists of 23 items, each scored 0 - 10, divided into three sub-scales. Higher scores mean decreased function.
Tegner activity scale (TAS)
The TAS determines a patient's activity level by grading their work and sports-based activity on a scale of 0 to 10. It is a one-item score and has proven its psychometric properties in knee surgery patients.
EuroQol-5 Dimensions 5 Level (EQ5D-5L)
EQ5D-5L has been shown to be responsive in detecting changes in patient health status after foot and ankle surgery. The EQ5D-5L is widely used as a general health status measures for a wide variety of conditions and enables comparisons of health-related quality of life between different conditions. A summary index is derived from the patients answers, by applying a specific formula.
Magnetic resonance Observation of Cartilage Repair Tissue (MOCART) score
The MOCART score was originally designed for evaluation of the cartilage in the knee, after procedures like microfracturing, and has a broad use to assess AMIC® in talus. The score is based on nine radiologic variables; degree of repair and defect filling, integration to border tissue, surface and structure of repair tissue, subchondral lamina and bone, adhesions and synovitis. The Score ranges from 0 - 100, where higher scores mean a better outcome.
Safety endpoints
Safety will be measured by freedom from device and procedure-related serious adverse events (SADEs) and all other Adverse Events (AEs) or Serious Adverse Events (SAEs) occurred.

Full Information

First Posted
February 1, 2023
Last Updated
June 13, 2023
Sponsor
Geistlich Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT05741983
Brief Title
AMIC vs. MFx in the Ankle
Acronym
AMARTA
Official Title
A Prospective, Double Blind, Single-centre, Randomised Controlled Trial Comparing Arthroscopic Autologous Matrix Induced Chondrogenesis (AMIC®) to Microfracture Alone in the Treatment of Osteochondral and Chondral Lesion in the Ankle (AMARTA)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geistlich Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical investigation is a prospective, double blind, single-centre, randomised controlled trial comparing arthroscopic autologous matrix induced chondrogenesis (AMIC®) to microfracture alone in the treatment of osteochondral and chondral lesion in the ankle to evaluate effectiveness, performance and safety of AMIC® procedure versus microfracture (MFx).
Detailed Description
This clinical investigation compares arthroscopic autologous matrix induced chondrogenesis (AMIC®) to microfracture alone in the treatment of osteochondral and chondral lesion in the ankle to evaluate effectiveness, performance and safety of AMIC® procedure versus microfracture (MFx). It is a prospective, double blind, single-centre, randomised controlled trial. The objective of this clinical investigation is to evaluate performance, effectiveness, and safety of AMIC® procedure versus Microfracture (MFx). The effectiveness of the treatment is measured by the difference in the walking/standing- part score taken from the Manchester Oxford Foot Questionnaire (MOX-FQ) from baseline to 12 months. The secondary endpoints concern clinical safety and performance. Patients will be randomized into two groups: Microfracture alone (MFx) or Bone Marrow Stimulation (Microfracture) with Chondro-Gide® (AMIC®). The investigational device will be assessed within its intended use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteochondral Lesion of Talus, Chondral Defect, Microfracture
Keywords
double-blind Randomised Controlled Trial (RCT), Chondro-Gide®, AMIC®

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind RCT (Randomized Controlled Trial)
Masking
ParticipantOutcomes Assessor
Masking Description
Patients will be blinded to the surgical procedure (with or without membrane). The outcome assessor who will complete the AOFAS and TAS will not be the physician who performed the surgery, the examiner is blinded to the treatment group to which the patient was allocated.
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AMIC®
Arm Type
Experimental
Arm Description
Bone Marrow Stimulation (Microfracture) with Chondro-Gide®
Arm Title
Microfracture (MFx)
Arm Type
Active Comparator
Arm Description
Microfracture alone
Intervention Type
Procedure
Intervention Name(s)
Microfracture (MFx)
Intervention Description
The ankle arthroscopy will be a standard procedure. The lesion will be identified, measured and prepared with curettage and soft tissue shaver. Preparation includes debridement of the unstable cartilage and in case of a chondral defect associated with a bone defect, the subchondral cyst is debrided. After debridement, the defect is classified and the lesion size is measured again.The microfracture will be performed with a microfracture awl. In cases of a chondral defect associated with a bone defect (osteochondral defect) the bone lesion must be treated concomitantly. Portal closure will be with steri-strips. All patients will follow the standard postoperative rehabilitation protocol including post op non-weight bearing and range of motion exercises for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Chondro-Gide®
Intervention Description
After the microfracture is performed and before the concomitant treatment of a bony lesion (if present), the defect size will be templated, and the membrane cut into its correct size. The joint is then drained and the membrane will be applied over the defect and stabilised with Fibrin glue. In cases of a osteochondral defect the bone lesion must be treated concomitantly. Once the bone defect has been treated, the Chondro-Gide® membrane is used to cover the site, and to support new cartilage tissue formation at the joint interface. Fluid will be reintroduced, and the stability of the membrane will be confirmed arthroscopically.
Primary Outcome Measure Information:
Title
Manchester Oxford Foot Questionnaire (MOX-FQ) walking/standing subscale
Description
The effectiveness of the treatment is measured by the difference in the walking/standing- part score taken from the the MOX-FQ from baseline to 12 months. Raw score values for the walking/standing part are between 0-28, where higher score mean a worse outcome. Raw scores are converted to a metric (0-100).
Time Frame
difference from baseline to 12 months post-operative
Secondary Outcome Measure Information:
Title
Manchester Oxford Foot Questionnaire (MOX-FQ) total
Description
The MOX-FQ is a commonly reported scoring system in the literature with proven acceptability, reliability and responsiveness for assessment of patients undergoing various foot and ankle surgeries. The total score consists of 3 subscales: Pain, Walking/ Standing and Social interaction. Raw score values for the total score are between 0-64, where higher score mean a worse outcome. Raw scores are converted to a metric (0-100).
Time Frame
change at 12, 24 and 60 months from baseline
Title
American Orthopaedic Foot and Ankle-Hind foot Score (AOFAS)
Description
The AOFAS has been used as a tool to measure the functional outcome after foot and ankle surgery and is often regarded as an essential outcome measure for all clinical studies. The score ranges from 0 - 100, where higher scores mean better outcomes.
Time Frame
change at 12, 24 and 60 months from baseline
Title
Foot Functioning Index (FFI)
Description
The FFI measures a patient's function in terms of pain, disability, and activity restriction to assess the impact of foot pathology. The index is self-administered and consists of 23 items, each scored 0 - 10, divided into three sub-scales. Higher scores mean decreased function.
Time Frame
change at 12, 24 and 60 months from baseline
Title
Tegner activity scale (TAS)
Description
The TAS determines a patient's activity level by grading their work and sports-based activity on a scale of 0 to 10. It is a one-item score and has proven its psychometric properties in knee surgery patients.
Time Frame
change at 12, 24 and 60 months from pre-symptomatic score
Title
EuroQol-5 Dimensions 5 Level (EQ5D-5L)
Description
EQ5D-5L has been shown to be responsive in detecting changes in patient health status after foot and ankle surgery. The EQ5D-5L is widely used as a general health status measures for a wide variety of conditions and enables comparisons of health-related quality of life between different conditions. A summary index is derived from the patients answers, by applying a specific formula.
Time Frame
change at 12, 24 and 60 months from baseline
Title
Magnetic resonance Observation of Cartilage Repair Tissue (MOCART) score
Description
The MOCART score was originally designed for evaluation of the cartilage in the knee, after procedures like microfracturing, and has a broad use to assess AMIC® in talus. The score is based on nine radiologic variables; degree of repair and defect filling, integration to border tissue, surface and structure of repair tissue, subchondral lamina and bone, adhesions and synovitis. The Score ranges from 0 - 100, where higher scores mean a better outcome.
Time Frame
change at 24 and 60 months from baseline
Title
Safety endpoints
Description
Safety will be measured by freedom from device and procedure-related serious adverse events (SADEs) and all other Adverse Events (AEs) or Serious Adverse Events (SAEs) occurred.
Time Frame
through study completion, an average of 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Signed written informed consent Diagnosis of symptomatic osteochondral or chondral lesion of the talus, deemed by surgeon amenable to arthroscopic treatment with debridement and microfracture Age of 18-65 years Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, the rehabilitation protocol and responding to patient questionnaire follow up Exclusion criteria: Lesions smaller 1 square centimeters and greater than 4 square centimeters based on the MRI Malalignment which is not corrected prior to or as part of same surgery Established significant hindfoot arthritis Patients who are unable to have an MRI scan Chronic inflammatory arthritis or infectious arthritis History of autoimmune disease or immunodeficiency History of connective tissue disease Intra-articular steroid use within the 3 months prior to enrolment Other intra-articular injections (e.g., hyaluronic acid) within 3 months prior to enrolment The patient is currently being treated with radiation, chemotherapy, immunosuppression, or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone Pregnancy or lactation Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the clinical investigation Active infection of the index ankle Has been prescribed medication to treat osteoporosis Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Schnüriger
Phone
+41 41 942 68 37
Email
nina.schnueriger@geistlich.com
First Name & Middle Initial & Last Name or Official Title & Degree
Despoina Natsiou Schmiady, Dr.
Phone
+41 41 492 68 11
Email
despoina.natsiou@geistlich.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Despoina Natsiou Schmiady, Dr.
Organizational Affiliation
Geistlich Pharma AG
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Torres Paulo, Mr.
Organizational Affiliation
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo Torres, Mr.

12. IPD Sharing Statement

Learn more about this trial

AMIC vs. MFx in the Ankle

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