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A Prospective Randomized Pilot Study to Compare Open Versus Percutaneous Syndesmosis Repair of Unstable Ankle Fractures

NCT02245893 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-02-26

No results posted yet for this study

Summary

This study evaluates fracture healing, anatomic reduction and return to functioning in patients with unstable Weber C type fractures of the ankle. Best outcomes are obtained when a good alignment of the ankle joint is maintained and natural function of the syndesmosis (space between the tibia and fibula bones) is restored. The syndesmosis and ankle joint is stabilized by a series of ligaments which are often damaged in Weber C type fractures. Current syndesmosis repair techniques traverse the tibia and fibula, but do not anatomically reconstruct the ligaments. The investigators will compare reconstruction of the unstable syndesmosis by open reduction and internal fixation using a syndesmosis screw coupled with anterior ligament (AiTFL) anatomic repair technique (ART) to percutaneous repair using a syndemosis screw only (SCREW). Radiographic, pain and functional outcome scores will be compared between the groups using validated outcome measures.

Conditions

  • Fracture Dislocation of Ankle Joint

Interventions

PROCEDURE

open reduction internal fixation (ORIF)

The study design is a prospective, randomized pilot clinical trial of the treatment of unstable syndesmosis injuries sustained with Weber C type fractures. Comparison will be made between two syndesmosis stabilization methods: 1) Percutaneous (closed) reduction using syndesmosis fixation by SCREW 2) Open reduction (ORIF) with ART repair of the anterior ligament and stabilization of the syndesmosis by use of a syndesmosis screw.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • David Sanders · Western Univeristy/Lawson Health ResearcH Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-09-30
Completion
2020-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02245893 on ClinicalTrials.gov