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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-04

Study Completion Date

2024-02-23

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.

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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.

Conditions

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Intertrochanteric Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Telescoping Lag Screw

Intertrochanteric fractures treated with Arthrex Hip Nail with Telescoping Screw

Telescoping Lag Screw

Intervention Type DEVICE

Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw

Standard lag Screw

Intertrochanteric fractures treated with Zimmer Natural Nail Cephalomedullary Nail

Standard lag Screw

Intervention Type DEVICE

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

Standard lag screw with addition of worm screw

Intertrochanteric fractures treated with Smith and Nephew TRIGEN INTERTAN

Standard lag screw with addition of worm screw

Intervention Type DEVICE

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

Interventions

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Telescoping Lag Screw

Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw

Intervention Type DEVICE

Standard lag Screw

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

Intervention Type DEVICE

Standard lag screw with addition of worm screw

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

Intervention Type DEVICE

Other Intervention Names

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Arthrex Hip Nail Zimmer Natural Nail Smith and Nephew TRIGEN INTERTAN

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No