Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Calcaneus Fracture
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 218
- Locations
- 14
- Primary Endpoint
- Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
Time Frame: Month 12
The primary outcome is return to work/duty as measured by the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. The IPAQ has moderate concordance with accelerometry-measured METs in an orthopaedic injury patient population. (one MET is defined as 3.5 mL O2 uptake/kg per min, which is the resting oxygen uptake in a sitting position). Less than 5 METS is poor, 5-8 METS is fair, 9-11 METS is good, and 12 METS or more is excellent.
Secondary Outcomes
- Triple Hop Performance Assessment Length(Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12)
- Pain Interference Scores(Week 6, Months 3 and 6 and 12)
- Dynamic Postural Stability Percentage(Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12)
- Number of Resource Utilizations(Week 6, Months 3 and 6)
- Rates of Symptomatic Arthritis - Kellgren Lawrence (KL) classification(1 year)
- Pain Intensity Scores(Week 6, Months 3 and 6 and 12)
- Union(1 year)
- Counter-Movement Jump - force dissipation (percent body weight/milliseconds)(Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12)
- Number of Return to Operating Room Visits(Week 6, Months 3 and 6)
- Counter-Movement Jump - force development (percent body weight/milliseconds)(Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12)
- Number of Complications(Week 6, Months 3 and 6)
- Current Pain Level Ratings(Week 6, Months 3 and 6 and 12)
- Veterans RAND 12 Item Health Survey (VR-12) Scores(Week 6, Months 3 and 6 and 12)
- Single Leg Static Percentage(Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12)
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores(Week 6, Months 3 and 6 and 12)
- Work Productivity and Activity Impairment Questionnaire Scores(Week 6, Months 3 and 6 and 12)
- Tampa Scale for Kinesiophobia (TSK) Scores(Week 6, Months 3 and 6 and 12)
- Rates of Symptomatic Arthritis - Paley Grading System (PGS)(1 year)
- Counter-Movement Jump - Height(Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12)