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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03906032
• Other study ID #: UHWHip#
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: April 2, 2023

Study information

• Verified date: September 2020
• Source: University Hospital Waterford
• Contact: May Cleary, FRCS
• Phone: 0035351848000
• Email: may.cleary[@]hse.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: April 2, 2023
• Est. primary completion date: April 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Function
• Gait Disorders, Neurologic
• Gait, Unsteady
• Hip Fractures

Intervention

Device:
• TFNA IM Nail
IM nail
• Sliding hip screw
SHS surgical fixation

Locations

Country	Name	City	State
Ireland	University Hospital Waterford	Waterford

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Waterford	DePuy Synthes

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Loss	Haemaglobin (Hb) day two measurement.	Mathematical model Day 2 Hb
Primary	Blood Loss	Haematocrit (Hct) at day two measurement.	Mathematical model Day 2 Hct
Primary	Mortality	Absolute	At any time point to 1 year post op
Primary	Analgesia Use	rate of opiate use	5 days
Primary	Timed up and go test	Tested measure of mobility and the change between baseline and subsequent time points	6 weeks, 6 months, 1 year
Primary	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
Primary	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	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.