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OpenTrials
Completed

NCT Number: NCT05094791

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

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Greenville Memorial Hosptial

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telescoping Lag Screw

Device

Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw

Other names: Arthrex Hip Nail

Standard lag Screw

Device

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

Device

Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw

Other names: Smith and Nephew TRIGEN INTERTAN

Primary outcomes

  1. Pain at lag screw

    Time frame: 6 weeks

    Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)

  2. Pain at lag screw

    Time frame: 12 weeks

    Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)

  3. Pain at lag screw

    Time frame: 21 weeks

    Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)

  4. Pain at lag screw

    Time frame: 52 weeks

    Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)

Secondary outcomes

  1. Radiographic lateralization of lag screw

    Time frame: 52 weeks

    Change in the lateralization of the lag screw measured in mm

  2. Incidence of lag screw injections

    Time frame: 52 weeks

    Incidence of patients requiring injections at the location of the lag screw due to pain

  3. Reoperation rate

    Time frame: 52 weeks

    Reoperations to the location in the intertrochanteric fractue

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Arthrex, Inc.

Registry information

Acronym: LIMIT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2021
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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