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

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ClinicalTrials.gov Identifier: NCT02032966
Recruitment Status : Active, not recruiting
First Posted : January 10, 2014
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Southeastern Fracture Consortium
Information provided by (Responsible Party):
University of Tennessee

Brief 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.


Condition or disease Intervention/treatment Phase
Ankle Fracture Malleolus Fracture Medial Malleolus Fracture Bimalleolar Fracture Trimalleolar Fracture Procedure: Nonsurgical Procedure: Surgical Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes Following Surgical Versus Nonsurgical Treatment of Fibular Fractures Following Operative Fixation of Unstable Medial Malleolus Fractures: A Prospective Randomized Study
Study Start Date : April 2011
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: 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: 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).

Active Comparator: 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.
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.

syndesmotic injury
Non-randomized / "syndesmotic injury": patients who have a positive ligament stress test (signifying a syndesmotic injury) during surgery will require surgical treatment of both the tibia and the fibula and cannot be randomized to either arm ("nonsurgical" versus "surgical"). Patients in this arm will still be included in the study for the collection of clinical and functional outcomes.
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.




Primary Outcome Measures :
  1. clinical outcomes [ Time Frame: one year ]
    Time to union (radiographic healing of the fracture), Time to weight-bearing, Complications


Secondary Outcome Measures :
  1. functional outcomes [ Time Frame: one year ]
    Measured by the SF-36 Health Survey and the Foot Function Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Skeletally mature patients ≥ 18 years of age with acute, closed bimalleolar and/or trimalleolar ankle fractures
  • Operative fixation of the ankle fracture is within 3 weeks from date of injury
  • Bimalleolar and/or trimalleolar ankle fractures in which the medial malleolus fragment is greater than 1.7cm wide on lateral x-ray imaging
  • Bimalleolar and/or trimalleolar ankle fractures in which the posterior malleolus fragment is less than 20% of the depth of the tibial articular surface

Exclusion Criteria:

  • Skeletally immature patients < 18 years of age
  • Single malleolar ankle fractures
  • Open fractures
  • Operative fixation of the ankle fracture is more than 3 weeks from date of injury
  • Bimalleolar and/or trimalleolar fractures in which the medial malleolar fragment is less than or equal to 1.7cm wide on lateral x-ray imaging
  • Bimalleolar and/or trimalleolar ankle fractures in which the posterior malleolus fragment is greater than or equal to 20% of the depth of the tibial articular surface
  • Ankles with previous fractures of the medial and/or lateral malleolus requiring operative intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032966


Locations
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United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Tennessee
Southeastern Fracture Consortium
Investigators
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Principal Investigator: Dirk W Kiner, M.D. UTCOM Chattanooga/Erlanger Health System

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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02032966     History of Changes
Other Study ID Numbers: 11-010
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Tennessee:
outcomes
surgical
non-surgical
ankle
malleolus
fracture
tibia
fibula
bimalleolar
trimalleolar
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries