NCT05094791

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intertrochanteric Fractures

Interventions

Type	Name	Description
DEVICE	Telescoping Lag Screw	Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw
DEVICE	Standard lag Screw	Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw
DEVICE	Standard lag screw with addition of worm screw	Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw

Timeline

• Start date: 2021-10-04
• Primary completion: 2024-02-23
• Completion: 2024-02-23
• First posted: 2021-10-26
• Last updated: 2024-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study