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Recruiting NCT06249126

Primary Subtalar Arthrodesis for Calcaneal Fractures

No phase Interventional Calcaneus Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA), Open Reduction Internal Fixation (ORIF) only.
Who it may be relevant to
Registry conditions: Calcaneus Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

The goal of this clinical trial is to compare two surgical options for calcaneus fractures to determine best treatment for returning to work sooner in adults.

Participants will be randomized to one of two treatment options and will be asked to complete patient reported outcome measure surveys.

Researchers will compare Open Reduction and Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) to ORIF alone to see which group returns to work at an earlier timepoint.

Interventions

  • Procedure Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)
    Definitive fixation by joint fusion
  • Procedure Open Reduction Internal Fixation (ORIF) only
    Definitive fixation with plates and screws

Primary outcome measures

  • Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score [Time frame: Week 6]
  • Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score [Time frame: Week 12]
  • Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score [Time frame: Month 6]
  • Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score [Time frame: Month 12]
Secondary outcome measures (12)
  • Number of Complications [Time frame: Week 6, Months 3 and 6]
  • Number of Return to Operating Room Visits [Time frame: Week 6, Months 3 and 6]
  • Number of Resource Utilizations [Time frame: Week 6, Months 3 and 6]
  • Rates of Symptomatic Arthritis - Kellgren Lawrence (KL) classification [Time frame: 1 year]
  • Rates of Symptomatic Arthritis - Paley Grading System (PGS) [Time frame: 1 year]
  • Current Pain Level Ratings [Time frame: Week 6, Months 3 and 6 and 12]
  • Union [Time frame: 1 year]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores [Time frame: Week 6, Months 3 and 6 and 12]
  • Veterans RAND 12 Item Health Survey (VR-12) Scores [Time frame: Week 6, Months 3 and 6 and 12]
  • Work Productivity and Activity Impairment Questionnaire Scores [Time frame: Week 6, Months 3 and 6 and 12]
  • Tampa Scale for Kinesiophobia (TSK) Scores [Time frame: Week 6, Months 3 and 6 and 12]
  • Counter-Movement Jump - Height [Time frame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12]

Eligibility criteria

Inclusion criteria

  • Undergoing operative treatment for displaced intra-articular calcaneus fracture
  • 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
  • Age 18 or older
  • Able to follow up at site for 1 year

Exclusion criteria

  • Planned surgery using extensile lateral approach
  • Sanders II displaced intra-articular calcaneus fracture without: Bohler angle < 0 degrees, open fracture, pain syndrome, or substance
  • <18 years of age
  • Body Mass Index (BMI) >40
  • Unable to follow up at site for 1 year
  • Patients that speak neither English or Spanish
  • Prisoner

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 17 centers
  • University of California, Irvine — Orange
  • Emory University, Grady Memorial Research Hospital — Atlanta
  • Atrium Health Navicent — Macon
  • The University of Chicago — Chicago
  • University of Kentucky — Lexington
  • Louisiana State University - University Medical Center New Orleans — New Orleans
  • University of Maryland Medical Center — Baltimore
  • Jamaica Hospital Medical Center — Jamaica
  • … and 9 more centers

Identifiers

NCT: NCT06249126 · IRB00107954 · HT94252310505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗