Lateral Ligament RepairNCT03064399
Microfracture Technique for Talar Articular Cartilage Lesions With or Without Lateral Ligament Repairment
A study testing without lateral ligament repairment and lateral ligament repairment in people with Lateral Ligament Repair and Talar Cartilage Lesion, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
Trial summary
To study the clinical efficacy of microfracture combined with lateral ligament repairment for cartilage lesions of talus through the comparison between microfracture with and without lateral ligament repairment. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Ligament Repair, Talar Cartilage Lesion, Microfracture
- What is being tested?
- without lateral ligament repairment and lateral ligament repairment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2017to 28 Feb 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full - thickness cartilage injury
Who cannot join
- Age: > 40 years old or < 18 years old; BMI > 30; lesion > 4 cm2
Trial locations and contacts
No sites are listed yet.
Yunfeng Yang, Doctor contact
About this study
Official title: Microfracture Technique for the Treatment of Articular Cartilage Lesions of the Talus With or Without Lateral Ligament Repairment
To study the clinical efficacy of microfracture combined with lateral ligament repairment for cartilage lesions of talus through the comparison between microfracture with and without lateral ligament repairment.
- Being tested
- without lateral ligament repairment, lateral ligament repairment
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without lateral ligament repairmentProcedure or surgery
microfracture without repairment of the lateral ligament
lateral ligament repairmentProcedure or surgery
microfracture combined with repairment of the lateral ligament
| Study group | Role | What they receive |
|---|---|---|
| lateral ligament repairment | Experimental | Not described Receives: Procedure: lateral ligament repairment |
| without lateral ligament repairment | Experimental | Not described Receives: Procedure: without lateral ligament repairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function score
AOFAS ankle function score
Measured: One year after surgery
Secondary outcomes (1)
Imaging result
Anatomical data from imaging results when bearing
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start28 Feb 2017 (estimated)
- Primary completion28 May 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Ligament RepairStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liming Cheng, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064399
- Sponsor's protocol ID
- 56014768-5
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfracture Technique for the Treatment of Articular Cartilage Lesions of the Talus With or Without Lateral Ligament Repairment
- ClinicalTrials.gov ID
- NCT03064399
- Acronym / sponsor ID
- 56014768-5
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Study start
- 28 Feb 2017 (estimated)
- Primary completion
- 28 May 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 27 Feb 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.
To study the clinical efficacy of microfracture combined with lateral ligament repairment for cartilage lesions of talus through the comparison between microfracture with and without lateral ligament repairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral ligament repairment | Experimental | Procedure: lateral ligament repairment |
| without lateral ligament repairment | Experimental | Procedure: without lateral ligament repairment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Full - thickness cartilage injury
Key exclusion criteria (1 listed)
- Age: > 40 years old or < 18 years old; BMI > 30; lesion > 4 cm2
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 |
|---|---|---|
| without lateral ligament repairmentmicrofracture without repairment of the lateral ligament | Procedure or surgery | without lateral ligament repairment |
| lateral ligament repairmentmicrofracture combined with repairment of the lateral ligament | Procedure or surgery | lateral ligament repairment |
Primary outcome
Function score
Time frame: One year after surgery
AOFAS ankle function score
1 secondary outcome
Imaging result
Time frame: One year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
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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.
Yunfeng Yang, Doctor contact
Questions about this trial
What is this clinical trial studying?
A study testing without lateral ligament repairment and lateral ligament repairment in people with Lateral Ligament Repair and Talar Cartilage Lesion, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunfeng Yang, Doctor (+86 13918588939), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function score (time frame: One year after surgery). 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 27 Feb 2017.