Back to resultsTreatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture
Primary Purpose
Ankle Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repair of deltoid ligament
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Fractures
Eligibility Criteria
Inclusion Criteria:
- ankle fracture with deltoid ligament rupture
Exclusion Criteria:
- ankle fracture without deltoid ligament rupture
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
with repair of deltoid ligament
without repair of deltoid ligament
Arm Description
open reduction and internal fixation with repair of deltoid ligament
open reduction and internal fixation without repair of deltoid ligament
Outcomes
Primary Outcome Measures
AOFAS score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02977910
Brief Title
Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture
Official Title
Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liming Cheng
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Comparative study for ankle fracture combined with deltoid ligament rupture: with & without repair of ligament
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
with repair of deltoid ligament
Arm Type
Experimental
Arm Description
open reduction and internal fixation with repair of deltoid ligament
Arm Title
without repair of deltoid ligament
Arm Type
No Intervention
Arm Description
open reduction and internal fixation without repair of deltoid ligament
Intervention Type
Procedure
Intervention Name(s)
repair of deltoid ligament
Intervention Description
intraoperative repair of deltoid ligament combined with ORIF
Primary Outcome Measure Information:
Title
AOFAS score
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ankle fracture with deltoid ligament rupture
Exclusion Criteria:
ankle fracture without deltoid ligament rupture
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28738797
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture
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