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

Primary Purpose

Ankle Fracture, Malleolus Fracture, Medial Malleolus Fracture

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nonsurgical
Surgical
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fracture focused on measuring outcomes, surgical, non-surgical, ankle, malleolus, fracture, tibia, fibula, bimalleolar, trimalleolar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erlanger Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Nonsurgical

Surgical

syndesmotic injury

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

clinical outcomes
Time to union (radiographic healing of the fracture), Time to weight-bearing, Complications

Secondary Outcome Measures

functional outcomes
Measured by the SF-36 Health Survey and the Foot Function Index

Full Information

First Posted
January 8, 2014
Last Updated
November 27, 2018
Sponsor
University of Tennessee
Collaborators
Southeastern Fracture Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT02032966
Brief Title
Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study
Official Title
Outcomes Following Surgical Versus Nonsurgical Treatment of Fibular Fractures Following Operative Fixation of Unstable Medial Malleolus Fractures: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
Collaborators
Southeastern Fracture Consortium

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture, Malleolus Fracture, Medial Malleolus Fracture, Bimalleolar Fracture, Trimalleolar Fracture
Keywords
outcomes, surgical, non-surgical, ankle, malleolus, fracture, tibia, fibula, bimalleolar, trimalleolar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nonsurgical
Arm Type
Experimental
Arm Description
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).
Arm Title
Surgical
Arm Type
Active Comparator
Arm Description
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.
Arm Title
syndesmotic injury
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nonsurgical
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Surgical
Intervention Description
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 Measure Information:
Title
clinical outcomes
Description
Time to union (radiographic healing of the fracture), Time to weight-bearing, Complications
Time Frame
one year
Secondary Outcome Measure Information:
Title
functional outcomes
Description
Measured by the SF-36 Health Survey and the Foot Function Index
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk W Kiner, M.D.
Organizational Affiliation
UTCOM Chattanooga/Erlanger Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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