Clinical trial NCT02198768: Ankle Fracture vs Ankle Fracture-Dislocation
Official title: Functional Outcome After Ankle Fractures and Ankle Fracture-Dislocations: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Fractures
Keywords: ankle fracture
ankle fracture-dislocation
prospective
observational
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population will be selected from Carolinas Medical Center Level I Trauma Center.

Brief summary: The purpose of this study is to compare outcomes of patients with an ankle fracture to those with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for patients sustaining ankle fracture dislocations are poorer than those without dislocation.

Detailed description: Orthopaedic literature has very limited data regarding outcomes following ankle fracture dislocations. Increased knowledge of the long-term consequences of these injuries could usher in changes to treatment paradigms, potentially resulting in improved outcomes. Thirty patients will be enrolled into two arms of this prospective study: isolated ankle fractures and ankle fracture dislocations. Patients will be followed through their operative and postoperative course and clinical and radiographic assessments will be analyzed. We plan to compare the clinical, radiographic, and functional outcomes of patients with ankle fractures to those with ankle fracture-dislocations. We also plan to identify factors that contribute to or predict poor clinical, functional, and/or radiographic outcomes in patients with ankle fractures and fracture-dislocations.

Eligibility criteria: Inclusion Criteria:

* Patients who sustain an isolated bi-malleolar or trimalleolar ankle fracture or an ankle fracture-dislocation requiring open reduction internal fixation
* Patients ages 18 and over
* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
* Open and closed fractures (excluding Gustilo grade 3)
* English must be patient's primary language

Exclusion Criteria:

* Previous injury or significant osteoarthritis to the affected ankle
* Current ipsilateral or contralateral lower extremity injury with the exception of a contralateral ankle fracture or fracture-dislocation
* Retained hardware from a previous injury at or around the tibia-talar joint of the affected extremity
* Patients under the age of 18
* History of inflammatory arthropathy
* Traumatic Brain Injury or Spinal Cord Injury preventing weightbearing on the lower extremities
* The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements
* Patients with Gustilo grade 3B and 3C open fractures

Primary outcomes:
measure: Change in Functional Outcome
timeFrame: 6, 12, and 24 months
Secondary outcomes:
measure: Radiographic Outcome
timeFrame: 24 month
Other outcomes:
measure: Additional surgical procedures
timeFrame: 2 years
measure: Postoperative Complications
timeFrame: 2 years
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center- Main
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Bosse, MD
role: PRINCIPAL_INVESTIGATOR
References: