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

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.

Study Overview

• Status: Completed
• Conditions: Intertrochanteric Fractures
• Intervention / Treatment: Device: Telescoping Lag Screw; Device: Standard lag Screw; Device: Standard lag screw with addition of worm screw

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients sustaining an intertrochantic hip fracture

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Telescoping Lag Screw; Intertrochanteric fractures treated with Arthrex Hip Nail with Telescoping Screw	Device: Telescoping Lag Screw; Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw; Other Names: Arthrex Hip Nail
Standard lag Screw; Intertrochanteric fractures treated with Zimmer Natural Nail Cephalomedullary Nail	Device: Standard lag Screw; Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw; Other Names: Zimmer Natural Nail
Standard lag screw with addition of worm screw; Intertrochanteric fractures treated with Smith and Nephew TRIGEN INTERTAN	Device: Standard lag screw with addition of worm screw; Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw; Other Names: Smith and Nephew TRIGEN INTERTAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic lateralization of lag screw	Change in the lateralization of the lag screw measured in mm	52 weeks
Incidence of lag screw injections	Incidence of patients requiring injections at the location of the lag screw due to pain	52 weeks
Reoperation rate	Reoperations to the location in the intertrochanteric fractue	52 weeks

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: Arthrex, Inc.
• Investigators: Principal Investigator: John D Adams, MD, Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: Pro00113048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes