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

Prisma Health-Upstate60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intertrochanteric Fractures

Interventions

Telescoping Lag ScrewDEVICE

Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw

Standard lag ScrewDEVICE

Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw

Standard lag screw with addition of worm screwDEVICE

Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

Greenville Memorial Hosptial

Greenville, South Carolina, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 52 weeks

Secondary Outcomes

Radiographic lateralization of lag screw

Change in the lateralization of the lag screw measured in mm

Time frame: 52 weeks

Incidence of lag screw injections

Incidence of patients requiring injections at the location of the lag screw due to pain

Time frame: 52 weeks

Reoperation rate

Reoperations to the location in the intertrochanteric fractue

Time frame: 52 weeks

Data from ClinicalTrials.gov

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