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

Intertrochanteric Fractures Clinical Trial

— LIMIT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05094791
• Other study ID #: Pro00113048
• Status: Enrolling by invitation
• Start date: October 4, 2021
• Est. completion date: June 4, 2024

Study information

• Verified date: November 2023
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 4, 2024
• Est. primary completion date: May 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures

Intervention

Device:
• Telescoping Lag Screw
Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw
• Standard lag Screw
Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw
• Standard lag screw with addition of worm screw
Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw

Locations

Country	Name	City	State
United States	Greenville Memorial Hosptial	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at lag screw	Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)	6 weeks
Primary	Pain at lag screw	Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)	12 weeks
Primary	Pain at lag screw	Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)	21 weeks
Primary	Pain at lag screw	Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)	52 weeks
Secondary	Radiographic lateralization of lag screw	Change in the lateralization of the lag screw measured in mm	52 weeks
Secondary	Incidence of lag screw injections	Incidence of patients requiring injections at the location of the lag screw due to pain	52 weeks
Secondary	Reoperation rate	Reoperations to the location in the intertrochanteric fractue	52 weeks