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 may impair gait, including decreased cadence, gait speed and increased double support time on the injured side.

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

Study Overview

• Status: Completed
• 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 an advantage of nailing over hip screw in intertrochanteric proximal femoral fractures. The current literature focus on outcome questionnaires, pain scores and basic functional tests alone may not delineate all functional benefits. 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 may impair gait, including decreased cadence and increased double support time on the injured side.

The cost differential between a nail and a SHS is a barrier to routine use of nailing in this population unless a clear benefit is demonstrated. Fracture nonunion is uncommon in this injury however improving functional outcome and reducing morbidity and mortality in this group is important.

In this prospective randomised study, the investigators examine whether an intramedullary nail (TFNA) results in a greater functional benefit in A1/A2 intertrochanteric fractures compared with the SHS, in terms of gait speed and other objective gait assessments, as well as other established post operative outcome measures.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Waterford, Ireland
    • University Hospital Waterford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• OTA Hip fracture grade A1 and A2
• Greater than 18 years old

Exclusion Criteria:

• Fracture less than 18 yrs old
• Fracture with lateral wall trochanteric comminution
• Poltrauma
• Concurrent lower limb fractures
• Immobile/wheelchair/bedbound patients
• High energy hip fractures
• Pathological fractures
• Reverse oblique and sub-trochanteric femoral fractures which are considered obligate TFNA at our centre
• Open wounds on affected limb
• Active psoriasis or other dermatological conditions at affected area
• Unable to gain consent from patient or patient's NOK

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
Kinmeatic Gait parameters at Hip	Rate of change in hip kinematic profile between baseline and subsequent time points,	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
Change in Heamoglobin concentration post surgery	Haemoglobin (Hb) day two measurement in grams per decilitre (g/dl)	Day 2 post surgery
Change in Heamatocrit concentration post surgery	Haematocrit day two measurement in litre of cells per litre of blood (L/L)	Day 2 post surgery
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
Radiographic assessment of fracture healing	Radiographic union as observed on plain radiographs at the stated time intervals (radiographic union score for hip total score of 10 - 30 points, minimum 10, maximum 30)	6 weeks, 6 months, 1 year
Radiographic assessment of femoral neck shortening	Radiographic assessment of any change in femoral neck length (in millimetres) between image on date of surgery and the 6 month post surgery image	6 months

Collaborators and Investigators

• Sponsor: University Hospital Waterford
• Collaborators: DePuy Synthes

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): June 2, 2025
• Study Completion (Actual): July 2, 2025

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): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: mobility; functional outcome; Timed up and go
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; 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