Osteochondral Lesion of TalusAMARTANCT05741983
AMIC vs. MFx in the Ankle
A study testing Microfracture (MFx) and Chondro-Gide® in people with Osteochondral Lesion of Talus and Chondral Defect, run by Geistlich Pharma AG at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteochondral Lesion of Talus, Chondral Defect, Microfracture
- What is being tested?
- Microfracture (MFx) and Chondro-Gide®
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Apr 2023to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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.
- Being tested
- Microfracture (MFx), Chondro-Gide®
- Keywords
- double-blind Randomised Controlled Trial (RCT), Chondro-Gide®, AMIC®
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfracture (MFx)Procedure or surgery
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| AMIC® | Experimental | Bone Marrow Stimulation (Microfracture) with Chondro-Gide® Receives: Procedure: Microfracture (MFx); Device: Chondro-Gide® |
| Microfracture (MFx) | Active comparator | Microfracture alone Receives: Procedure: Microfracture (MFx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: difference from baseline to 12 months post-operative
Secondary outcomes (7)
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).
Measured: change at 12, 24 and 60 months from baseline
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.
Measured: change at 12, 24 and 60 months from baseline
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.
Measured: change at 12, 24 and 60 months from baseline
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.
Measured: change at 12, 24 and 60 months from pre-symptomatic score
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.
Measured: change at 12, 24 and 60 months from baseline
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.
Measured: change at 24 and 60 months from baseline
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.
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start28 Apr 2023
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Why it stopped: unsatisfactory patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesion of TalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind RCT (Randomized Controlled Trial)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Despoina Natsiou Schmiady, Dr., Study director, Geistlich Pharma AGTorres Paulo, Mr., Principal investigator, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741983
- Sponsor's protocol ID
- 13575-236
- Acronym
- AMARTA
- Status last verified
- Mar 2024
- First submitted
- 1 Feb 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05741983
- Acronym / sponsor ID
- AMARTA / 13575-236
- Keywords
- double-blind Randomised Controlled Trial (RCT), Chondro-Gide®, AMIC®
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unsatisfactory patient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind RCT (Randomized Controlled Trial)
| Arm | Type | Receives |
|---|---|---|
| AMIC® | Experimental | Procedure: Microfracture (MFx), Device: Chondro-Gide®Bone Marrow Stimulation (Microfracture) with Chondro-Gide® |
| Microfracture (MFx) | Active comparator | Procedure: Microfracture (MFx)Microfracture alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfracture (MFx)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. | Procedure or surgery | AMIC®, Microfracture (MFx) |
| Chondro-Gide®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. | Device | AMIC® |
Primary outcome
Manchester Oxford Foot Questionnaire (MOX-FQ) walking/standing subscale
Time frame: difference from baseline to 12 months post-operative
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).
7 secondary outcomes
Manchester Oxford Foot Questionnaire (MOX-FQ) total
Time frame: change at 12, 24 and 60 months from baseline
American Orthopaedic Foot and Ankle-Hind foot Score (AOFAS)
Time frame: change at 12, 24 and 60 months from baseline
Foot Functioning Index (FFI)
Time frame: change at 12, 24 and 60 months from baseline
Tegner activity scale (TAS)
Time frame: change at 12, 24 and 60 months from pre-symptomatic score
EuroQol-5 Dimensions 5 Level (EQ5D-5L)
Time frame: change at 12, 24 and 60 months from baseline
Magnetic resonance Observation of Cartilage Repair Tissue (MOCART) score
Time frame: change at 24 and 60 months from baseline
Safety endpoints
Time frame: through study completion, an average of 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Despoina Natsiou Schmiady, Dr. study director
Geistlich Pharma AG
Torres Paulo, Mr. principal investigator
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfracture (MFx) and Chondro-Gide® in people with Osteochondral Lesion of Talus and Chondral Defect, run by Geistlich Pharma AG at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manchester Oxford Foot Questionnaire (MOX-FQ) walking/standing subscale (time frame: difference from baseline to 12 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.