Lateralization After IntraMedullary Nailing of InterTrochanteric Hip Fractures, Clinical and Radiographic Outcomes

Study Overview
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Brief Summary
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Intertrochanteric fractures are commonly stabilized using an intramedullary nail with a lag screw that enters the lateral cortex of the femur. This lag screw commonly protrudes during the healing process and may cause implant related pain. This study will help determine if implant related pain is different depending to the lag screw design.

Detailed Description
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This study compares cephalomedullary fixation of intertrochanteric femur fractures using the Arthrex Hip Nail System with a telescoping lag screw compared to the Zimmer Natural Nail and the Smith and Nephew InterTan. This pilot study will evaluate radiographic outcomes and lateral sided hip pain related to different lag screw designs used for patients with intertrochanteric femur fractures by comparing outcomes of patients receiving 3 different lag screws The primary objective of this study is to compare pain at the level of the lag screw of patients with collapsible lag screws compared to patient who received a standard lag screw using a numeric rating scale on a 0-100 scale.

Official Title
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Lateralization After IntraMedullary Nailing of InterTrochanteric Hip Fractures, Clinical and Radiographic Outcomes

Conditions
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Intertrochanteric Fractures

Intervention / Treatment
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* Device: Telescoping Lag Screw
* Device: Standard lag Screw
* Device: Standard lag screw with addition of worm screw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients greater than or equal to 22 years of age who undergo treatment of an intertrochanteric hip fracture with an intramedullary nail. Fluoroscopic views of the final fixation construct or a post-operative radiograph taken within 24 hours must be available. Exclusion Criteria: Non-ambulatory prior to injury (patient must do more than only transfers) Cognitive deficiencies that prevent the patient from providing their own informed consent Inability to follow-up at the discretion of the investigator (incarceration, moving out of area, no permanent housing) Prior fracture to injured hip Prior surgery to injured hip Basi-cervical fracture pattern (fracture that begins above the lesser trochanter and exits medial to the greater trochanter) Patients not treated within 48 hours of admission Chronic or acute infection at site of surgery Language barrier preventing completion of study forms in English Open fracture Fracture related to neoplasm

Ages Eligible for Study
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Minimum Age: 22 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Telescoping Lag Screw<br>Intertrochanteric fractures treated with Arthrex Hip Nail with Telescoping Screw | Device: Telescoping Lag Screw<br>* Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw<br>* Other names: Arthrex Hip Nail;|
| Standard lag Screw<br>Intertrochanteric fractures treated with Zimmer Natural Nail Cephalomedullary Nail | Device: Standard lag Screw<br>* Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw<br>* Other names: Zimmer Natural Nail;|
| Standard lag screw with addition of worm screw<br>Intertrochanteric fractures treated with Smith and Nephew TRIGEN INTERTAN | Device: Standard lag screw with addition of worm screw<br>* Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw<br>* Other names: Smith and Nephew TRIGEN INTERTAN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at lag screw | Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100) | 6 weeks | 
| Pain at lag screw | Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100) | 12 weeks | 
| Pain at lag screw | Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100) | 21 weeks | 
| Pain at lag screw | Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100) | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic lateralization of lag screw | Change in the lateralization of the lag screw measured in mm | 52 weeks | 
| Incidence of lag screw injections | Incidence of patients requiring injections at the location of the lag screw due to pain | 52 weeks | 
| Reoperation rate | Reoperations to the location in the intertrochanteric fractue | 52 weeks |