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

Prisma Health-Upstate

Status

Completed

Conditions

Intertrochanteric Fractures

Treatments

Device: Standard lag screw with addition of worm screw

Device: Telescoping Lag Screw

Device: Standard lag Screw

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05094791

Pro00113048

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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