Clinical trial NCT06249126: Primary Subtalar Arthrodesis for Calcaneal Fractures
Official title: Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Calcaneus Fracture
Keywords: heel injuries
post-traumatic subtalar arthritis
orthopaedic injury
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
timeFrame: Week 6
measure: Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
timeFrame: Week 12
measure: Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
timeFrame: Month 6
measure: Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
timeFrame: Month 12
Secondary outcomes:
measure: Number of Complications
timeFrame: Week 6, Months 3 and 6
measure: Number of Return to Operating Room Visits
timeFrame: Week 6, Months 3 and 6
measure: Number of Resource Utilizations
timeFrame: Week 6, Months 3 and 6
measure: Rates of Symptomatic Arthritis - Kellgren Lawrence (KL) classification
timeFrame: 1 year
measure: Rates of Symptomatic Arthritis - Paley Grading System (PGS)
timeFrame: 1 year
measure: Current Pain Level Ratings
timeFrame: Week 6, Months 3 and 6 and 12
measure: Union
timeFrame: 1 year
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
timeFrame: Week 6, Months 3 and 6 and 12
measure: Veterans RAND 12 Item Health Survey (VR-12) Scores
timeFrame: Week 6, Months 3 and 6 and 12
measure: Work Productivity and Activity Impairment Questionnaire Scores
timeFrame: Week 6, Months 3 and 6 and 12
measure: Tampa Scale for Kinesiophobia (TSK) Scores
timeFrame: Week 6, Months 3 and 6 and 12
measure: Counter-Movement Jump - Height
timeFrame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
measure: Counter-Movement Jump - force development (percent body weight/milliseconds)
timeFrame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
measure: Counter-Movement Jump - force dissipation (percent body weight/milliseconds)
timeFrame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
measure: Single Leg Static Percentage
timeFrame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
measure: Dynamic Postural Stability Percentage
timeFrame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
measure: Triple Hop Performance Assessment Length
timeFrame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
measure: Pain Intensity Scores
timeFrame: Week 6, Months 3 and 6 and 12
measure: Pain Interference Scores
timeFrame: Week 6, Months 3 and 6 and 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Temple Terrace
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University, Grady Memorial Research Hospital
state: Georgia
city: Macon
country: United States
facility: Atrium Health Navicent
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University - University Medical Center New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina Foot and Ankle Institute
state: North Carolina
city: Concord
country: United States
facility: Atrium Health Cabarrus
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph R Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: