RECRUITING

Primary Subtalar Arthrodesis for Calcaneal Fractures

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Conditions

Calcaneus Fractureheel injuriespost-traumatic subtalar arthritisorthopaedic injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Management of severe injuries to the heel (displaced intra-articular calcaneus fractures) continues to be a major challenge for orthopedic surgeons. Previous studies have demonstrated poor outcomes, and results show that patients experience long-term pain and decreased quality of life postoperatively. Poor outcomes are driven by pain, in particular, which is linked to post-traumatic subtalar arthritis.

Official Title

Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial

Quick Facts

Study Start:2024-09-02
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06249126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing operative treatment for displaced intra-articular calcaneus fracture
  2. * Sanders III and IV displaced intra-articular calcaneus fracture OR Sanders II with any of the following criteria: Bohler angle \< 0 degrees, open fracture, pain syndrome, substance use disorder
  3. * Age 18 or older
  4. * Able to follow up at site for 1 year
  1. * Planned surgery using extensile lateral approach
  2. * Sanders II displaced intra-articular calcaneus fracture without: Bohler angle \< 0 degrees, open fracture, pain syndrome, or substance
  3. * \<18 years of age
  4. * Body Mass Index (BMI) \>40
  5. * Unable to follow up at site for 1 year
  6. * Patients that speak neither English or Spanish
  7. * Prisoner

Contacts and Locations

Study Contact

Christine Churchill
CONTACT
704-355-6947
Christine.Churchill@atriumhealth.org

Principal Investigator

Joseph R Hsu, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 35233
United States
Yale University School of Medicine
New Haven, Connecticut, 06510
United States
Atrium Health Navicent
Macon, Georgia, 31201
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Louisiana State University - University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27546
United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
OrthoCarolina Foot and Ankle Institute
Charlotte, North Carolina, 28204
United States
Atrium Health Cabarrus
Concord, North Carolina, 28025
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Prisma Health
Greenville, South Carolina, 29605
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
The University of Texas Medical Branch
Galveston, Texas, 77555
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Joseph R Hsu, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-02
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-09-02
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • heel injuries
  • post-traumatic subtalar arthritis
  • orthopaedic injury

Additional Relevant MeSH Terms

  • Calcaneus Fracture