Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture

Prospective Randomized Controlled Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture

Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations impairs gait, including decreased cadence and increased double support time on the injured side.

The use of a IM nail device may stop this shortening and improve functional parameters in this patient cohort

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures; Gait, Unsteady; Function
• Intervention / Treatment: Device: TFNA IM Nail; Device: Sliding hip screw

Detailed Description

Published work in this field to date has not demonstrated a clear advantage of nailing over hip screw in intertrochanteric proximal femoral fractures. The current lierature focus on outcome questionnaires, pain scores and basic functional tests alone does not delineate the functional benefits clearly enough. A key factor in whether a person, post hip fracture, returns to independent living is gait speed. The cost implications on the healthcare provider of having 30% of this ever increasing group losing their independence and requiring admission to a care facility post hip fracture is a growing problem.

Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations impairs gait, including decreased cadence and increased double support time on the injured side.

The difference in cost between a nail and a SHS is a driver to prevent routine use of nailing in this population unless a clear benefit is demonstrated. Fracture union is not a problem for the most part and, as such, the focus must be on achieving better functional outcome, less morbidity and less mortality in this group.

The key question to answer is whether a IM Nail (TFNA) results in a greater functional benefit in A1/A2 intertrochanteric fractures compared with the SHS.

• Study Type: Interventional
• Enrollment (Anticipated): 352
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: May Cleary, FRCS; Phone Number: 0035351848000; Email: may.cleary@hse.ie

Study Locations

• Ireland
  • Waterford, Ireland
    • Recruiting
    • University Hospital Waterford
    • Contact: May Cleary; Phone Number: 0035351848000; Email: may.cleary@hse.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• OTA Hip fracture grade A1 and A2
• Greater than 60 years old

Exclusion Criteria:

• Polytrauma, high-energy hip fractures, pathological fractures,
• Reverse oblique and sub-trochanteric femoral fractures
• less than 60 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-medullary hip Nail; Surgery	Device: TFNA IM Nail; IM nail
Active Comparator: Sliding hip screw; Surgery	Device: Sliding hip screw; SHS surgical fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	Haemaglobin (Hb) day two measurement.	Mathematical model Day 2 Hb
Blood Loss	Haematocrit (Hct) at day two measurement.	Mathematical model Day 2 Hct
Mortality	Absolute	At any time point to 1 year post op
Analgesia Use	rate of opiate use	5 days
Timed up and go test	Tested measure of mobility and the change between baseline and subsequent time points	6 weeks, 6 months, 1 year
Harris Hip score	Functional scale of hip pain and the change between baseline and subsequents time points. Maximum score: 100 points indicating excellent function, minimum score 0 points indicating poor function.	6 weeks, 6 months, 1 year
Kinmeatic Gait parameters at Hip	Rate of change in hip kinmeatic profile between baseline and subsequent time points	6 weeks, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	the duration of hospital stay after this procedure has wide variability between 3 days and weeks to months.	Through to study completion at one year post operatively.

Collaborators and Investigators

• Sponsor: University Hospital Waterford
• Collaborators: DePuy Synthes

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Anticipated): April 2, 2022
• Study Completion (Anticipated): April 2, 2023

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: mobility; functional outcome; Timed up and go
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Gait Disorders, Neurologic
• Other Study ID Numbers: UHWHip#

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: No
• product manufactured in and exported from the U.S.: No