Calcaneus FractureNCT06249126
Primary Subtalar Arthrodesis for Calcaneal Fractures
A study testing Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) and Open Reduction Internal Fixation (ORIF) only in people with Calcaneus Fracture, run by Wake Forest University Health Sciences at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcaneus Fracture
- What is being tested?
- Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) and Open Reduction Internal Fixation (ORIF) only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 17 sitesUnited States
- Study dates
- 2 Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Recruiting
Emory University, Grady Memorial Research Hospital
Atlanta, Georgia, 30303
Morgan Fuller, 404-251-8953, Mrfulle@emory.edu
Jason Barron, jason.barron@emory.edu
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Mark Gage, MD
Andrea Howe, ahowe@som.umaryland.edu
- Recruiting
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27546
Andrew Chen, MD
Andrew Chen, MD
- Recruiting
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
Rachel B Seymour, PhD
Christine Churchill, MA
- Recruiting
OrthoCarolina Foot and Ankle Institute
Charlotte, North Carolina, 28204
Samuel E Ford, MD
Zach Hutchko, zachery.hutchko@orthocarolina.com
- Not yet recruiting
The University of Chicago
Chicago, Illinois, 60637
Ashley Mayo, 773-906-4605, Ashley.Mayo@bsd.uchicago.edu
Brianna Fram, MD
- Recruiting
Atrium Health Cabarrus
Concord, North Carolina, 28025
Luke Harmer, MD
Erica Grochowski, MPH
- Not yet recruiting
The University of Texas Medical Branch
Galveston, Texas, 77555
Joseph Wenke, MD
Joseph Wenke, MD
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
Kyle Jeray, MD
Emily Williams, emily.williams8@prismahealth.org
- Not yet recruiting
Jamaica Hospital Medical Center
Jamaica, New York, 11418
Akiva Sugerman, 718-206-6923, ASUGERMA@jhmc.org
Abhishek Ganta, MD
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Paul Matuszewski, MD, 859-323-5533, pmatuszewski@uky.edu
Matthew Eubank
- Recruiting
Atrium Health Navicent
Macon, Georgia, 31201
Jarrod Dumpe, MD
Adithi Shyam, adithi.shyam@advocatehealth.org
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Bethany Gallagher, MD
Karen Trochez
- Not yet recruiting
Louisiana State University - University Medical Center New Orleans
New Orleans, Louisiana, 70112
Carolyn Bridgman
Jessica Rivera, MD
- Not yet recruiting
NYC Health and Hospital/Bellevue
New York, New York, 10016
Nina Fisher, MD
Ivanka Bhambhani, Ivanka.Bhambhani@nyulangone.org
- Recruiting
University of California, Irvine
Orange, California, 92868
Susan Demas, 714-456-7012, sdemas@hs.uci.edu
John Scolaro, MD
- Not yet recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Martha Holden
Jason Halvorson, MD
About this study
Official title: Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Calcaneus Fracture
- Being tested
- Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA), Open Reduction Internal Fixation (ORIF) only
- Keywords
- heel injuries, post-traumatic subtalar arthritis, orthopaedic injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)Procedure or surgery
Definitive fixation by joint fusion
Open Reduction Internal Fixation (ORIF) onlyProcedure or surgery
Definitive fixation with plates and screws
| Study group | Role | What they receive |
|---|---|---|
| Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) | Other | Surgical fixation by joint fusion + Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together Receives: Procedure: Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) |
| Open Reduction Internal Fixation (ORIF) only | Other | Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together Receives: Procedure: Open Reduction Internal Fixation (ORIF) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
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.
Measured: Week 6
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
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.
Measured: Week 12
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
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.
Measured: Month 6
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
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.
Measured: Month 12
Secondary outcomes (19)
Number of Complications
Major complications, including infection, nonunion, malunion, and hardware failure will be captured from the medical record.
Measured: Week 6, Months 3 and 6
Number of Return to Operating Room Visits
Details regarding reoperations will be collected, especially in cases of hardware removal and those randomized to Open Reduction Internal Fixation (ORIF) who receive secondary subtalar fusion.
Measured: Week 6, Months 3 and 6
Number of Resource Utilizations
Healthcare utilization, including new hospitalizations, emergency department visits, clinic visits, imaging, and physical therapy sessions will be documented at all follow-up visits
Measured: Week 6, Months 3 and 6
Rates of Symptomatic Arthritis - Kellgren Lawrence (KL) classification
If post-traumatic osteoarthritis (PTOA) is present, Kellgren Lawrence (KL) classification (This semiquantitative approach primarily evaluates osteophytes and joint space narrowing to assign a score between 0 (no ROA) to 4 (severe ROA) will be assessed by the panel of reviewers and documented.
Measured: 1 year
Rates of Symptomatic Arthritis - Paley Grading System (PGS)
If post-traumatic osteoarthritis (PTOA) is present, the Paley Grading System (PGS) will be assessed by the panel of reviewers and documented - type 1: tibial shortening alone with a normal ankle (A); type 2: tibial shortening with dynamic valgus at the ankle (B)
Measured: 1 year
Current Pain Level Ratings
Pain will be assessed using the Numeric Rating Scale. Patients will be asked to rate their current pain at each visit. Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: Week 6, Months 3 and 6 and 12
Union
Union, as determined by the treating surgeon, will be assessed via radiographs and documented as a dichotomous outcome (yes/no), and time to union will also be captured. Nonunion will be captured via surgeon diagnosis or return to the operating room for nonunion treatment.
Measured: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
The PROMIS-29 is a free to use, publicly available generic health related quality of life measure that includes seven domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. A 5-point Likert scale is used for each question and norm-based total scores (range 0-100) have been calculated so that 50 represents the mean and one standard deviation is 10 points. Additionally, higher scores represent better function.
Measured: Week 6, Months 3 and 6 and 12
Veterans RAND 12 Item Health Survey (VR-12) Scores
The VR-12 is a measure of global health that correspond to seven domains: general health, physical functioning, role limitations, pain, fatigue, social functioning, and mental health. Together, these items are summarized into a Physical Component Score and a Mental Component Score. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Measured: Week 6, Months 3 and 6 and 12
Work Productivity and Activity Impairment Questionnaire Scores
If return to duty/work is reported, patients will complete the Work Productivity and Activity Impairment Questionnaire, a validated instrument that measures work time missed and work and activity impairment due to health problems. Measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. The higher number of day equates to more health problems
Measured: Week 6, Months 3 and 6 and 12
Tampa Scale for Kinesiophobia (TSK) Scores
This scale is 17 items and uses a 4-point Likert scale ranging from 'strongly disagree' to 'strongly agree'. The TSK is a validated measure for surgical and musculoskeletal patients. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
Measured: Week 6, Months 3 and 6 and 12
Counter-Movement Jump - Height
Patients will be asked to perform a double-leg and single-leg countermovement jump to assess jump height. Patients will be asked to perform three repetitions of countermovement jump for maximal height off of a force plate followed by landing on the same force plate. The average jump height (centimeters),will be calculated across the three trials.
Measured: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Counter-Movement Jump - force development (percent body weight/milliseconds)
Patients will be asked to perform a double-leg and single-leg countermovement jump to assess concentric force development (take-off) (VALD Force Deck System). Patients will be asked to perform three repetitions of countermovement jump for force development (percent body weight/milliseconds) and will be calculated across the three trials.
Measured: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Counter-Movement Jump - force dissipation (percent body weight/milliseconds)
Patients will be asked to perform a double-leg and single-leg countermovement jump to assess force dissipation (landing) (VALD Force Deck System). Patients will be asked to perform three repetitions of countermovement jump for maximal height off of a force plate followed by landing on the same force plate. The average jump force dissipation (percent body weight/milliseconds) will be calculated across the three trials.
Measured: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Single Leg Static Percentage
Static postural stability will be assessed under eyes open and eyes closed conditions. The average of three 10-second trials will be collected for data analysis for each condition. The variable to be analyzed will the standard deviation of resultant ground reaction force across the 10-second trial. It will be a percentage.
Measured: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Dynamic Postural Stability Percentage
Dynamic postural stability will be assessed during a single-leg landing. Patients will be asked to jump forward to the force plate, clear a 30.5 cm hurdle, land on the force plate with their test leg only, stabilize as quickly as possible, and maintain balance with their hands on their hips for ten seconds. A total of three trials will be collected and averaged together for analysis. A stability index based on the three ground reaction force components will be calculated. The unit of Force will be in percent body weight. It will be a percentage. The higher the percentage, indicating better stability.
Measured: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Triple Hop Performance Assessment Length
Bilateral assessment of jump performance will be performed during a triple hop (cross-over) for maximum distance. Participants will be provided a practice trial at 50 percent maximum effort prior to the test trials and testing will begin with non-surgical left first. Participants will begin the jump behind zero-inch line, which marks the starting point. Participants will perform three consecutive jumps off one leg while crossing over the tape with each jump so that the first jump is lateral, the second jump is medial, and the final jump is lateral. Participants will be asked to hold their place at the end of the third jump until their distance is recorded. Three test trials will be assessed for each leg and averaged together for analysis.
Measured: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Pain Intensity Scores
Pain will be assessed using the Brief Pain Inventory (BPI). The BPI is a commonly used and validated 15-item measure of pain intensity and interference with daily life. Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Measured: Week 6, Months 3 and 6 and 12
Pain Interference Scores
Pain will be measured with the pain intensity and pain interference Patient-Reported Outcomes Measurement Information System (PROMIS) domains. Score on a scale from 0 to 100, where higher Pain Intensity and Pain Interference scores indicate inferior outcomes
Measured: Week 6, Months 3 and 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start2 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneus FractureStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph R Hsu, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249126
- Sponsor's protocol ID
- IRB00107954
- Other IDs
- HT94252310505
- Status last verified
- May 2026
- First submitted
- 30 Jan 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06249126
- Acronym / sponsor ID
- IRB00107954
- Conditions
- Calcaneus Fracture
- Keywords
- heel injuries, post-traumatic subtalar arthritis, orthopaedic injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) | Other | 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 |
| Open Reduction Internal Fixation (ORIF) only | Other | Procedure: Open Reduction Internal Fixation (ORIF) onlySurgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)Definitive fixation by joint fusion | Procedure or surgery | Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) |
| Open Reduction Internal Fixation (ORIF) onlyDefinitive fixation with plates and screws | Procedure or surgery | Open Reduction Internal Fixation (ORIF) only |
Primary outcome
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
Time frame: Week 6
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.
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
Time frame: Week 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.
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
Time frame: Month 6
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.
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.
19 secondary outcomes
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
Counter-Movement Jump - force development (percent body weight/milliseconds)
Time frame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Counter-Movement Jump - force dissipation (percent body weight/milliseconds)
Time frame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Single Leg Static Percentage
Time frame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Dynamic Postural Stability Percentage
Time frame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Triple Hop Performance Assessment Length
Time frame: Upon being cleared for high level activity, Week 6, Months 3 and 6 and 12
Pain Intensity Scores
Time frame: Week 6, Months 3 and 6 and 12
Pain Interference Scores
Time frame: Week 6, Months 3 and 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph R Hsu, MD principal investigator
Wake Forest University Health Sciences
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) and Open Reduction Internal Fixation (ORIF) only in people with Calcaneus Fracture, run by Wake Forest University Health Sciences at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Churchill (704-355-6947, Christine.Churchill@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score (time frame: Week 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.