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Status unknownNCT02977910Updated Nov 30, 2016

Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture

An interventional study of repair of deltoid ligament in Ankle Fractures, sponsored by Liming Cheng. Status unknown. Per ClinicalTrials.gov, last updated 2016-11-30.

Sponsored by Liming Cheng · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study 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. 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

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Conditions studied

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In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 200 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

This is the only study on the registry with Liming Cheng as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ankle fracture with deltoid ligament rupture

Exclusion criteria

Exclusion Criteria:

  • ankle fracture without deltoid ligament rupture
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    with repair of deltoid ligament

    open reduction and internal fixation with repair of deltoid ligament

    Procedure: repair of deltoid ligament

  • No intervention
    without repair of deltoid ligament

    open reduction and internal fixation without repair of deltoid ligament

Interventions

  • Procedurerepair of deltoid ligament

    intraoperative repair of deltoid ligament combined with ORIF

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What researchers measure

Primary outcomes

  1. AOFAS score

    Time frame: 12 months after surgery

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02977910
Lead sponsor
Liming Cheng
Responsible party
Liming Cheng (Director, Head of orthopedics, Pricipal investigator, Clinical professor, Shanghai Tongji Hospital, Tongji University School of Medicine) — Sponsor-investigator
First posted
Nov 30, 2016
Start date
Jan 2017
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Nov 30, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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