The Hip Fracture Surgical Approach Trial

Study Overview
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Brief Summary
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The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients.

Detailed Description
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Femoral neck fractures are mostly treated with a hemiarthroplasty, where the fractured femoral head is replaced with a metal implant. The most common surgical approach to hemiarthroplasty has been the lateral approach, in which the gluteus medius tendon is partially released from the greater trochanter. Hip pain and limping is not uncommon after this approach has been used. A new surgical approach (SPAIRE) has been developed to alleviate this problem, and in this method the surgeon approaches the injured hip joint from posterior, preserving most of the muscles and tendons around the hip. This trial is designed to assess if this new SPAIRE approach leads to better results than the lateral approach in patients with femoral neck fractures.

Official Title
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The Hip Fracture Surgical Approach Trial

Conditions
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Hip Fracture, Femoral Neck Fracture

Intervention / Treatment
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* Procedure: Direct lateral approach
* Procedure: SPAIRE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Femoral neck fracture Clinical indication for hemiarthroplasty Age over 50 years Exclusion Criteria: Previous hip implants in the same hip Patients assessed to be in a terminal state with an expected survival of less than 1 week Other factors that makes follow-up impossible

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct lateral approach<br> | Procedure: Direct lateral approach<br>* The hip joint is approached from laterally, and parts of the gluteus medius tendon is released from the greater trochanter before the hip joint is entered from the anterior side.<br>* Other names: Hardinge approach;|
| Experimental: Spaire approach<br> | Procedure: SPAIRE<br>* The hip joint is entered from posterior, and the approach preserves the external rotators of the hip joint.<br>* Other names: Muscle-sparing modification of the posterior approach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score ( HHS) | Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best). | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (HHS) | Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, presence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best). | 12 and 24 months | 
| Oxford Hip score | Oxford Hip Score(OHS) is a patient reported outcome measure( PROM), OHS is designed to assess outcome after total hip replacement. It has 6 questions on pain and 6 questions on mobility. 5 categories of answer from worst to best. The range is 0-48. | 0, 4,12 and 24 months | 
| EuroQol-5d-5l | EuroQol-5d-5l is a descriptive system comprises 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state, and these digits can be converted into a single numerical value reflecting how the health state is according to the preferences of the general population of a country/region. | 4,12 and 24 months | 
| Trendelenburg test | This is a test to identify weakness in gluteal muscles, that can be seen in patients after hip surgery. Unilateral weakness in the gluteal muscles can for instance because nerve damage, trauma to the muscle or rupture of the tendon. The test will be performed as described by Hardcastle and Wade. The patient will be asked to raise their foot from the ground with 30º of hip flexion. The patient will be instructed to raise the non-stance side of the pelvis as high as possible with the examiner supporting the patient by holding their hands if needed. If the patient is not able to maintain this position for 30 seconds, or not being able to raise the hip of the non-stance side to above the level of the stance-side, the Trendelenburg test is considered positive. | 4,12 and 24 months | 
| New Mobility Score (NMS) | NMS consists of 3 questions about ambulation indoor, outdoor and the ability to go shopping. Each question has 4 alternative answers yielding 0-3 points, and the maximum score is 9. | 4,12 and 24 months | 
| Short Physical Performance Battery (SPPB) | The Short Physical Performance Battery is an assessment tool made specific for screening of physical function among older adults. SPPB has 3 different tests: Balance, walking speed and rising from a chair. Scorings range from 0-12, best possible is 12. | 4, 12, an 24 months | 
| Numerical Pain Rate Scale( NPRS) | Unidimensional measure of pain intensity in adults, describing pain extreme from 0 no pain at all to 10 the worst pain imaginable. | 4, 12 and 24 months | 
| Blood transfusion | Units of blood transfusion given to the patient during admission | 1st day after surgery until discharge, assessed up to 10 days | 
| Duration of surgery | Duration of the operation in minutes | 1.st day after surgery | 
| Conventional radiographs of the operated hip | Conventional radiographs will be taken postoperatively and at 4 months according to the standardized procedures for post-operative hip examinations of the radiology department. Using specialized computer software (Sectra Workstation IDS7 v.21 with orthopedic templating module Sectra Orthostation v15.1, Sectra AB, Linköping, Sweden), leg length difference, and hip offset compared to the uninjured hip will be recorded. In patients with a contralateral hip fracture this is not possible, but some of these patients will have available pre-fracture examinations that can be utilized for comparison. Femoral stem varus/valgus angulation (frontal view) and retroversion/anteversion (lateral view) will also be recorded | 1.st day after surgery and at 4 months after surgery | 
| Adverse events | Any adverse events will be recorded during the whole study period | 0-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPAIRE, Fragility fracture, Surgical approach, Hemiarthroplasty, Direct Lateral Approach, Hip Surgery