Computer-Assisted Fixation of Trochanteric Femur Fractures

Study Overview
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Brief Summary
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The purpose of this study is to assess whether the Stryker© ADAPT™ augmented-reality platform can assist surgeons in optimizing placement of the lag screw component of the Stryker© Gamma™ cephalomedullary nail.

Detailed Description
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This will be a prospective, randomized, single-blinded, controlled trial with two treatment cohorts. Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw. Patients will be blinded to treatment group allocation as will clinicians/researchers during data processing and analysis. The primary outcome will be tip-apex distance, as measured on anteroposterior and lateral hip radiographs. Secondary outcomes will be position of the lag screw as described by Cleveland et al, operative time, fluoroscopy time, and number of Kirschner wire passes prior to final placement of the lag screw. Additionally, evidence of lag screw cutout on hip radiographs, hip range of motion relative to the contralateral hip, overall mobility, social dependency, and pain level will be assessed at 3 month, 6 month, 1 year, and 2 year follow up visits.

Official Title
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Computer-Assisted Surgery for Internal Fixation of Peritrochanteric Femur Fractures: A Randomized Controlled Study

Conditions
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Hip Fractures

Intervention / Treatment
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* Device: Stryker© ADAPT™ platform
* Radiation: Traditional fluoroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Patients aged 18 years and older with isolated closed peritrochanteric femur fractures who are candidates for surgical fixation with a cephalomedullary nail device Exclusion criteria: Patients with open peritrochanteric femur fractures or multiple injuries (i.e., polytrauma) Patients with peritrochanteric femur fractures better treated with a device other than a cephalomedullary nail, as determined by the attending orthopedic surgeon Patients less than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 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: Patients will be divided into two treatment arms: cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™platform to assist with insertion of the lag screw.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional fluoroscopy<br>Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care). | Radiation: Traditional fluoroscopy<br>* For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail.<br>|
| Experimental: Stryker© ADAPT™ platform<br>Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™platform to assist with insertion of the lag screw. | Device: Stryker© ADAPT™ platform<br>* The ADAPT system is a software platform that utilizes augmented reality to assist surgeons with implant alignment, lag screw length and positioning, and distal interlocking screw placement for cephalomedullary fixation of peritrochanteric femur fractures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tip-apex distance (TAD) | Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays | Immediate post-operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lag screw position | Lag screw position in the femoral head/neck as described by Cleveland et al. (1959) | Immediate postoperative period | 
| Operative time | The amount of time required to complete the surgical procedure | Intraoperative period | 
| Fluoroscopy time | The amount of fluoroscopy utilized during the surgical procedure as measured in seconds | Intraoperative period | 
| K-wire passes | The total number of K-wire passes prior to final lag screw placement | Intraoperative period | 
| Evidence of lag screw cut-out | Evidence of lag screw cut-out as seen on postoperative hip radiographs | 3 months, 6 months, 1 year, and 2 years after surgery | 
| Hip range of motion | Postoperative range of motion of the affected hip as measured on physical examination | 3 months, 6 months, 1 year, and 2 years after surgery | 
| Patient mobility and social dependency | Postoperative patient mobility and social dependency as defined by the Harris Hip Score | 3 months, 6 months, 1 year, and 2 years after surgery | 
| Pain level | Postoperative pain level as defined by the visual analog scale | 3 months, 6 months, 1 year, and 2 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritrochanteric femur fractures