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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Hip Fractures, Gait, Unsteady, Function

Intervention / Treatment
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* Device: TFNA IM Nail
* Device: Sliding hip screw


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Timed up and go, mobility, functional outcome