Ankle Fracture vs Ankle Fracture-Dislocation

NCT02198768 | Completed DMC

• 1 other identifier: 06-12-03A
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures

Keywords

ankle fracture; ankle fracture-dislocation; prospective; observational

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiographic Outcome

  24 month

Other Outcomes (2)

• Additional surgical procedures

  2 years

• Postoperative Complications

  2 years

Study Arms (2)

Ankle Fracture

Patients with isolated ankle fractures.

Ankle Fracture-Dislocation

Patients with ankle fracture-dislocations.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center- Main

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Michael Bosse, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: July 24, 2014
• Study Start: September 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 25, 2022

Record last verified: 2017-01

Locations

US (1)