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

Completed

• Conditions: Intertrochanteric Fractures
• Interventions: Device: Standard lag Screw; Device: Telescoping Lag Screw; Device: Standard lag screw with addition of worm screw

• Registration Number: NCT05094791
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

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

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 Timeline

• Study Start: 2021-10-04
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-26
• Primary Completion: 2024-02-23
• Study Completion: 2024-02-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard lag Screw	Standard lag Screw	Intertrochanteric fractures treated with Zimmer Natural Nail Cephalomedullary Nail
Telescoping Lag Screw	Telescoping Lag Screw	Intertrochanteric fractures treated with Arthrex Hip Nail with Telescoping Screw
Standard lag screw with addition of worm screw	Standard lag screw with addition of worm screw	Intertrochanteric fractures treated with Smith and Nephew TRIGEN INTERTAN

Primary Outcome Measures

Name	Time	Method
Pain at lag screw	52 weeks	Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)

Secondary Outcome Measures

Name	Time	Method
Radiographic lateralization of lag screw	52 weeks	Change in the lateralization of the lag screw measured in mm
Incidence of lag screw injections	52 weeks	Incidence of patients requiring injections at the location of the lag screw due to pain
Reoperation rate	52 weeks	Reoperations to the location in the intertrochanteric fractue

Trial Locations

Locations (1)

Greenville Memorial Hosptial; 🇺🇸 Greenville, South Carolina, United States