Clinical trial NCT02032966: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Fracture
Malleolus Fracture
Medial Malleolus Fracture
Bimalleolar Fracture
Trimalleolar Fracture
Keywords: outcomes
surgical
non-surgical
ankle
malleolus
fracture
tibia
fibula
bimalleolar
trimalleolar
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Southeastern Fracture Consortium
First posted: 2014-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: clinical outcomes
timeFrame: one year
Secondary outcomes:
measure: functional outcomes
timeFrame: one year
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
Study officials:
affiliation: UTCOM Chattanooga/Erlanger Health System
name: Dirk W Kiner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: