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Ankle Fracture vs Ankle Fracture-Dislocation

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ClinicalTrials.gov Identifier: NCT02198768
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Bosse, Carolinas Healthcare System

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.

Condition or disease
Ankle Fractures

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.

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Outcome After Ankle Fractures and Ankle Fracture-Dislocations: A Prospective Study
Study Start Date : September 2012
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Ankle Fracture
Patients with isolated ankle fractures.
Ankle Fracture-Dislocation
Patients with ankle fracture-dislocations.



Primary Outcome Measures :
  1. Change in Functional Outcome [ Time Frame: 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 :
  1. Radiographic Outcome [ Time Frame: 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.


Other Outcome Measures:
  1. Additional surgical procedures [ Time Frame: 2 years ]
    Documentation of any additional surgical procedures conducted on the affected ankle. Any surgical procedure will be noted. These may include debridement for infection or dehiscence, revision for hardware failure, arthroscopy, ankle arthrodesis, or cartilage restoration procedures.

  2. Postoperative Complications [ Time Frame: 2 years ]
    Postoperative complications will be documented and analyzed to determine if there are significant differences between the two groups. These will include infection requiring antibiotics or debridement, hardware failure, nerve or vascular injury, deep venous thrombosis, or revision surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population will be selected from Carolinas Medical Center Level I Trauma Center.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198768


Locations
United States, North Carolina
Carolinas Medical Center- Main
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Michael Bosse, MD Carolinas Healthcare System

Responsible Party: Michael Bosse, PI, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT02198768     History of Changes
Other Study ID Numbers: 06-12-03A
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data Sharing will need to be discussed with investigators.

Keywords provided by Michael Bosse, Carolinas Healthcare System:
ankle fracture
ankle fracture-dislocation
prospective
observational

Additional relevant MeSH terms:
Fractures, Bone
Joint Dislocations
Ankle Fractures
Fracture Dislocation
Wounds and Injuries
Bone Diseases
Musculoskeletal Diseases