Talar Osteochondral Defect of AnkleNCT03371121
Clinical and Radiographic Outcomes After AMIC Treatment for Talus Osteochondral Lesion Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC
A study testing AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis) in people with Talar Osteochondral Defect of Ankle and Pain, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Aim of the study is to evaluate clinical and radiographic outcomes in patients undergone all-arthroscopic autologous matrix induced chondrogenesis for symptomatic osteochondral talar lesions Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Talar Osteochondral Defect of Ankle, Pain, Arthroscopy
- What is being tested?
- AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2016to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age over 18 years
- males and females
- patients underwent arthroscopic cartilage reconstruction surgery with AMIC technique for osteochondral lesions of the talus
Who cannot join
- age <18 years at the time of surgery
- patients with previous surgery on the affected ankle
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Valutazione Dell'Epidemiologia e Dei Risultati Radiografici e Clinici Nel Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC
Aim of the study is to evaluate clinical and radiographic outcomes in patients undergone all-arthroscopic autologous matrix induced chondrogenesis for symptomatic osteochondral talar lesions
- Conditions
- Talar Osteochondral Defect of Ankle, Pain, Arthroscopy
- Being tested
- AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)Other
to fill arthroscopically osteochondral talar lesion
| Study group | Role | What they receive |
|---|---|---|
| Chondro-gide - Geistlich | Other | Arthroscopic use of chondro-gide to treat symptomatic osteochondral talar lesion Receives: Other: AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic reduction of the lesion
A reduction of at least 30% of the lesion is to be expected
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start26 Apr 2016
- Primary completionFeb 2019 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Talar Osteochondral Defect of AnkleStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico G Usuelli, MD, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371121
- Sponsor's protocol ID
- AMIC
- Status last verified
- Dec 2017
- First submitted
- 7 Dec 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Dell'Epidemiologia e Dei Risultati Radiografici e Clinici Nel Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC
- ClinicalTrials.gov ID
- NCT03371121
- Acronym / sponsor ID
- AMIC
- Conditions
- Talar Osteochondral Defect of Ankle, Pain, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Dec 2017 (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.
Aim of the study is to evaluate clinical and radiographic outcomes in patients undergone all-arthroscopic autologous matrix induced chondrogenesis for symptomatic osteochondral talar lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chondro-gide - Geistlich | Other | Other: AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)Arthroscopic use of chondro-gide to treat symptomatic osteochondral talar lesion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- males and females
- patients underwent arthroscopic cartilage reconstruction surgery with AMIC technique for osteochondral lesions of the talus
Key exclusion criteria (2 listed)
- age <18 years at the time of surgery
- patients with previous surgery on the affected ankle
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 |
|---|---|---|
| AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)to fill arthroscopically osteochondral talar lesion | Other | Chondro-gide - Geistlich |
Primary outcome
Radiologic reduction of the lesion
Time frame: 5 years
A reduction of at least 30% of the lesion is to be expected
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Talar Osteochondral Defect of Ankle
Active, not recruitingObservational study
Ten Years Follow-up After the Arthroscopic Repair of Osteochondral Lesions of the Talus Via Autologous Matrix-induced Chondrogenesis (AMIC)
Osteochondral Defect of Talus
Enrolling by invitationObservational study
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle
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.
Federico G Usuelli, MD principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis) in people with Talar Osteochondral Defect of Ankle and Pain, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Dec 2017. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico G Usuelli, MD (00393357351838, fusuelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiologic reduction of the lesion (time frame: 5 years). 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 13 Dec 2017.