Clinical trial NCT05094791: Lateralization After IntraMedullary Nailing of InterTrochanteric Hip Fractures, Clinical and Radiographic Outcomes
Official title: Lateralization After IntraMedullary Nailing of InterTrochanteric Hip Fractures, Clinical and Radiographic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intertrochanteric Fractures
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2021-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients sustaining an intertrochantic hip fracture

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain at lag screw
timeFrame: 6 weeks
measure: Pain at lag screw
timeFrame: 12 weeks
measure: Pain at lag screw
timeFrame: 21 weeks
measure: Pain at lag screw
timeFrame: 52 weeks
Secondary outcomes:
measure: Radiographic lateralization of lag screw
timeFrame: 52 weeks
measure: Incidence of lag screw injections
timeFrame: 52 weeks
measure: Reoperation rate
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Memorial Hosptial
state: South Carolina
Study officials:
affiliation: Prisma Health
name: John D Adams, MD
role: PRINCIPAL_INVESTIGATOR
References: