CompletedNot Applicable

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

United States60 participantsStarted 2021-10-04

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain at lag screw

Timeframe: 6 weeks

Pain at lag screw

Timeframe: 12 weeks

Pain at lag screw

Timeframe: 21 weeks

Pain at lag screw

Timeframe: 52 weeks

Trial details

NCT IDNCT05094791

SponsorPrisma Health-Upstate

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-23

View on ClinicalTrials.gov More Intertrochanteric Fractures trials

Plain-language summary

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.