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

NCT05094791 | Completed FDA Device

• 1 other identifier: Pro00113048
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intertrochanteric Fractures

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Radiographic lateralization of lag screw

  52 weeks

• Incidence of lag screw injections

  52 weeks

• Reoperation rate

  52 weeks

Study Arms (3)

Telescoping Lag Screw

Intertrochanteric fractures treated with Arthrex Hip Nail with Telescoping Screw

Device: Telescoping Lag Screw

Standard lag Screw

Intertrochanteric fractures treated with Zimmer Natural Nail Cephalomedullary Nail

Device: Standard lag Screw

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

Interventions

Telescoping Lag Screw DEVICE

Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw

Also known as: Arthrex Hip Nail

Telescoping Lag Screw

Standard lag Screw DEVICE

Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw

Also known as: Zimmer Natural Nail

Standard lag Screw

Standard lag screw with addition of worm screw DEVICE

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

Also known as: Smith and Nephew TRIGEN INTERTAN

Standard lag screw with addition of worm screw

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients sustaining an intertrochantic hip fracture

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Greenville Memorial Hosptial

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• John D Adams, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 26, 2021
• Study Start: October 4, 2021
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)