Ankle FracturesNCT02977910
Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture
A study testing repair of deltoid ligament in people with Ankle Fractures, run by Liming Cheng.
Trial summary
Ankle fracture is very common which is often combined with deltoid ligament injury. Although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- repair of deltoid ligament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ankle fracture with deltoid ligament rupture
Who cannot join
- ankle fracture without deltoid ligament rupture
About this study
Official title: Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture
Ankle fracture is very common which is often combined with deltoid ligament injury. Although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. There is no high-level, multi-center, large sample, long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is necessary or not. The main content of the project: 1 Achieve accurate classification of deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications and treatment guidelines by comparative study.
Read the detailed description
Comparative study for ankle fracture combined with deltoid ligament rupture: with \& without repair of ligament
- Conditions
- Ankle Fractures
- Being tested
- repair of deltoid ligament
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repair of deltoid ligamentProcedure or surgery
intraoperative repair of deltoid ligament combined with ORIF
| Study group | Role | What they receive |
|---|---|---|
| with repair of deltoid ligament | Experimental | open reduction and internal fixation with repair of deltoid ligament Receives: Procedure: repair of deltoid ligament |
| without repair of deltoid ligament | No intervention | open reduction and internal fixation without repair of deltoid ligament |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS score
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liming Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liming Cheng, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977910
- Sponsor's protocol ID
- 56014768-4
- Status last verified
- Nov 2016
- First submitted
- 23 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fan J, Zhang X, Luo Y, You GW, Ng WK, Yang YF. Tibiotalocalcaneal (TTC) arthrodesis with reverse PHILOS plate and medial cannulated screws with lateral approach. BMC Musculoskelet Disord. 2017 Jul 24;18(1):317. doi: 10.1186/s12891-017-1666-2.
PubMed 28738797
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture
- ClinicalTrials.gov ID
- NCT02977910
- Acronym / sponsor ID
- 56014768-4
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Liming ChengUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- 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.
Ankle fracture is very common which is often combined with deltoid ligament injury. Although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. There is no high-level, multi-center, large sample, long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is necessary or not. The main content of the project: 1 Achieve accurate classification of deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications and treatment guidelines by comparative study.
Detailed description
Comparative study for ankle fracture combined with deltoid ligament rupture: with \& without repair of ligament
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with repair of deltoid ligament | Experimental | Procedure: repair of deltoid ligamentopen reduction and internal fixation with repair of deltoid ligament |
| without repair of deltoid ligament | No intervention | –open reduction and internal fixation without repair of deltoid ligament |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ankle fracture with deltoid ligament rupture
Key exclusion criteria (1 listed)
- ankle fracture without deltoid ligament rupture
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 |
|---|---|---|
| repair of deltoid ligamentintraoperative repair of deltoid ligament combined with ORIF | Procedure or surgery | with repair of deltoid ligament |
Primary outcome
AOFAS score
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Derived from this study: PubMed 28738797Fan J, Zhang X, Luo Y, You GW, Ng WK, Yang YF. Tibiotalocalcaneal (TTC) arthrodesis with reverse PHILOS plate and medial cannulated screws with lateral approach. BMC Musculoskelet Disord. 2017 Jul 24;18(1):317. doi: 10.1186/s12891-017-1666-2.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing repair of deltoid ligament in people with Ankle Fractures, run by Liming Cheng.
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 30 Nov 2016. 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?
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?
AOFAS score (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02977910, which also lists 1 linked publication.
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 30 Nov 2016.