Ankle Fracture vs Ankle Fracture-Dislocation

Functional Outcome After Ankle Fractures and Ankle Fracture-Dislocations: A Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center- Main

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population will be selected from Carolinas Medical Center Level I Trauma Center.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Outcome	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.	6, 12, and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Outcome	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.	24 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional surgical procedures	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 years
Postoperative Complications	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.	2 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Michael Bosse, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 24, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: prospective; observational; ankle fracture; ankle fracture-dislocation
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Fractures, Bone; Joint Dislocations; Ankle Fractures; Fracture Dislocation
• Other Study ID Numbers: 06-12-03A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data Sharing will need to be discussed with investigators.