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Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study

NCT02032966 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-28

No results posted yet for this study

Summary

Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an ankle fracture in which both the tibia and the fibula are broken. This would alleviate the need for another incision, plate, and screws to repair the fibula. The purpose of this study is to help determine if surgically repairing only the tibia fracture will lead to equivalent clinical outcomes when compared with surgical repair of both bones.

The hypothesis of this study is that operative stabilization of the medial malleolus fracture only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the ankle, will lead to equivalent clinical outcomes and functional scores as those treated with operative stabilization of both malleoli and/or all malleoli.

Conditions

  • Ankle Fracture
  • Malleolus Fracture
  • Medial Malleolus Fracture
  • Bimalleolar Fracture
  • Trimalleolar Fracture

Interventions

PROCEDURE

Nonsurgical

Randomized to "nonsurgical": patient will receive surgical treatment of the inside portion (medial malleolus) of the tibia fracture only; the fibula fracture (and posterior malleolus fracture, if present) will be closed reduced (not repaired surgically).

PROCEDURE

Surgical

Randomized to "surgical": patient will receive surgical treatment of both the inside portion (medial malleolus) of the tibia fracture, as well as the fibula fracture (lateral malleolus). Fixation of the posterior side of the tibia (posterior malleolus) may or may not be performed based upon intraoperative x-rays.

Sponsors & Collaborators

  • Southeastern Fracture Consortium

    collaborator UNKNOWN

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Dirk W Kiner, M.D. · UTCOM Chattanooga/Erlanger Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • United States

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 NCT02032966 on ClinicalTrials.gov