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

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University of Tennessee

Status

Unknown

Conditions

Medial Malleolus Fracture
Ankle Fracture
Malleolus Fracture
Bimalleolar Fracture
Trimalleolar Fracture

Treatments

Procedure: Nonsurgical
Procedure: Surgical

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups

Nonsurgical
Experimental group
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).
Treatment:
Procedure: Nonsurgical
Surgical
Active Comparator group
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.
Treatment:
Procedure: Surgical
syndesmotic injury
Other group
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.
Treatment:
Procedure: Surgical

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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