Ankle Fracture vs Ankle Fracture-Dislocation

Completed

• Conditions: Ankle Fractures

• Registration Number: NCT02198768
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-24
• Primary Completion: 2016-11
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Functional Outcome	6, 12, and 24 months	Clinical and functional outcomes will be measured using the Foot and Ankle Ability Measure (FAAM) and the Short Form Musculoskeletal Functional Assessment (SMFA).; Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.

Secondary Outcome Measures

Name	Time	Method
Radiographic Outcome	24 month	Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.

Trial Locations

Locations (1)

Carolinas Medical Center- Main; 🇺🇸 Charlotte, North Carolina, United States