AMIC vs. MFx in the Ankle

NCT05741983 | Withdrawn

• 1 other identifier: 13575-236
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteochondral Lesion of Talus; Chondral Defect; Microfracture

Keywords

double-blind Randomised Controlled Trial (RCT); Chondro-Gide®; AMIC®

Outcome Measures

Primary Outcomes (1)

• 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).

  difference from baseline to 12 months post-operative

Secondary Outcomes (7)

• Manchester Oxford Foot Questionnaire (MOX-FQ) total

  change at 12, 24 and 60 months from baseline

• American Orthopaedic Foot and Ankle-Hind foot Score (AOFAS)

  change at 12, 24 and 60 months from baseline

• Foot Functioning Index (FFI)

  change at 12, 24 and 60 months from baseline

• Tegner activity scale (TAS)

  change at 12, 24 and 60 months from pre-symptomatic score

• EuroQol-5 Dimensions 5 Level (EQ5D-5L)

  change at 12, 24 and 60 months from baseline

Study Arms (2)

AMIC®

EXPERIMENTAL

Bone Marrow Stimulation (Microfracture) with Chondro-Gide®

Procedure: Microfracture (MFx); Device: Chondro-Gide®

Microfracture (MFx)

ACTIVE COMPARATOR

Microfracture alone

Procedure: Microfracture (MFx)

Interventions

Microfracture (MFx) PROCEDURE

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.

AMIC®; Microfracture (MFx)

Chondro-Gide® DEVICE

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.

AMIC®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geistlich Pharma AG: lead

Study Sites (1)

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Despoina Natsiou Schmiady, Dr.

  Geistlich Pharma AG

  STUDY DIRECTOR

• Torres Paulo, Mr.

  Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind RCT (Randomized Controlled Trial)

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 23, 2023
• Study Start: April 28, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

GB (1)