NCT02977910

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

November 23, 2016

Last Update Submit

November 26, 2016

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (1)

  • AOFAS score

    12 months after surgery

Study Arms (2)

with repair of deltoid ligament

EXPERIMENTAL

open reduction and internal fixation with repair of deltoid ligament

Procedure: repair of deltoid ligament

without repair of deltoid ligament

NO INTERVENTION

open reduction and internal fixation without repair of deltoid ligament

Interventions

repair of deltoid ligamentPROCEDURE

intraoperative repair of deltoid ligament combined with ORIF

with repair of deltoid ligament

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ankle fracture with deltoid ligament rupture

You may not qualify if:

  • ankle fracture without deltoid ligament rupture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28738797DERIVED

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Head of orthopedics, Pricipal investigator, Clinical professor

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 30, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 30, 2016

Record last verified: 2016-11