Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 29
- 主要终点
- Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Open Reduction Internal Fixation (ORIF) only
Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
干预措施: Open Reduction Internal Fixation (ORIF) only (Procedure)
Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)
Surgical fixation by joint fusion + Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
干预措施: Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) (Procedure)
结局指标
主要结局
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
时间窗: 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.
次要结局
- 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)