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Search / Trial NCT02198768

Ankle Fracture vs Ankle Fracture-Dislocation

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jul 22, 2014

Trial Information

Current as of May 02, 2025

Completed

Keywords

Ankle Fracture Ankle Fracture Dislocation Prospective Observational

ClinConnect Summary

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 outcom...

Gender

ALL

Eligibility 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

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Charlotte, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Michael Bosse, MD

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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