Ankle Fracture vs Ankle Fracture-Dislocation

NCT ID: NCT02198768

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Ankle Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ankle Fracture

Patients with isolated ankle fractures.

No interventions assigned to this group

Ankle Fracture-Dislocation

Patients with ankle fracture-dislocations.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Bosse, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Carolinas Medical Center- Main

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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06-12-03A

Identifier Type: -

Identifier Source: org_study_id

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