InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery

Study Overview
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Brief Summary
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The goal of this pilot, patient blinded randomized trial is to develop a mechanistic understanding of gait following fixation of unstable intertrochanteric hip fractures and return to function and pain control. The guiding hypothesis that will be tested in a subsequent clinicial trial is that the InterTAN when compared to standard lag-screw cephalomedullary nails will have decreased post operative pain, earlier return to symmetric weight bearing, and quicker return to pre-injury functioning levels.

Detailed Description
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Aim 1: Determine the feasibility of conducting a randomized trial assessing gait mechanics as well as outcomes following unstable intertrochanteric femur fractures treated with cephalomedullary nails. This will be achieved by performing a pilot randomized trial comparing the InterTAN versus a single-screw design cephalomedullary nail (SSCMN). Deliverable: Preliminary data to support a larger randomized trial powered on either mechanical assessments or patient reported outcomes. Feasibility of conducting comprehensive biomechanical and patient related outcome measurements in the geriatric hip fracture population. Aim 2: Determine the pathway to return to function and symmetric weight bearing. Load bearing will be assessed through insole monitoring during their inpatient stay and 2-weeks post-op. Additionally, analysis will be performed to measure gait for hip motion, loading, strength and functional assessments at 6,12, and 26 weeks post-op. Patients will also be assessed at 1-year for reported function as well. Hypothesis: Patients in the InterTAN group will have faster return to symmetrical weight bearing/motion and earlier return to function. Deliverable: Longitudinal data assessing return to function and weight bearing in intertrochanteric femur fractures. Aim 3: Determine if use of the InterTAN device when compared to SSCMN results in decreased pain following unstable intertrochanteric femur fractures. Patients will be enrolled in a prospective trial with standardized pain control regimen, assessing patients for pain during their hospital stay using Area Under the Curve Analysis of Visual Analogue Pain Scores at 24, 48 and 72 hours. Similarly, opioid usage in morphine milligram equivalents will be assessed. Pain will be assessed at follow-up visits 6, 12, 26, 52 weeks. Hypothesis: The InterTAN will result in decreased pain in the immediate post-operative period and in sub-acute post-operative period. Aim 4: Determine if the use of the InterTAN device when compared to SSCMN results in decreased healthcare utilization. Participation with therapy, hospital length of stay, discharge disposition, and time-spent in rehabilitation facility will be assessed. Hypothesis: Patients in the InterTAN group will be more likely to be discharged home, participate with therapy more, have decreased length of stay in both inpatient and outpatient units. Deliverable: Data to inform the power analysis for a larger prospective clinical trial.

Official Title
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Does an Integrated Dual Screw Design Improve Biomechanics and Function Following Fixation of Unstable Intertrochanteric Femur Fractures: A Randomized Pilot Trial (InterTAN)

Conditions
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Fracture of Hip

Intervention / Treatment
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* Device: Synthes TFNA
* Device: Trigen InterTAN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-pathologic fractures OTA/AO classification 31A2, 31A3 fractures Ability to participate in 4-MET equivalent activities without ambulatory assistance prior to injury Exclusion Criteria: Inability to consent Inability to participate in follow-up activities History of chronic pain / current opioid treatment Pre-injury ambulatory status requiring assistance device Neurological condition altering gait or sensation (e.g. History of stroke with altered gait, peripheral neuropathy).

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot, patient blinded randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trigen InterTan<br>Patients in this arm will be implanted with the cephalomedullary nail Trigen InterTan manufactured by Smith & Nephew. | Device: Trigen InterTAN<br>* Surgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN.<br>|
| Active Comparator: Synthes TFNA<br>Patients in this arm will be implanted with the single-screw device TFNA manufactured by DePuy Synthes. | Device: Synthes TFNA<br>* Surgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported physical function | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function. | 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months | 
| Change in self-reported pain | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Questionnaire is a 56 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates increased interference due to pain. | 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Independence Measure | The Functional Independence Measure (FIM) is a tool used to measure the level of disability as well as the change in patient status. FI is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. | 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months | 
| Change in pain assessment | Brief Pain Inventory (BPI) will be used to measure pain intensity. This is a four-item scale that measures current, worst, least, and average pain. Each of these four items are measured on a numeric scale from 0 to 10 with 0 being ''no pain'' and 10 being ''severe pain.'' | 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months | 
| Change in weight bearing | The ground reaction forces of the injured and non injured limb will be evaluated over the course of recovery to assess when loading between limbs becomes symmetric during their physical therapy. | 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months | 
| Change in Visual Analog Pain Score | The visual analog pain score is a horizontal line with a scale ranging from 0 to 10 where a higher number indicates more pain. | 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Fixation, Cephalomedullary nail