Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

Study Overview
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Brief Summary
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Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. Also is there a difference in heterotopic ossification at 12 months.

Detailed Description
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Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468). This study is a follow-up on the same study population. 150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be operated With either anterolateral og Direct lateral surgical approach. Investigators want to compare the radiological features of the femoral stem between the two Groups.

Official Title
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Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach: A Follow-up of a Randomized Controlled Trial.

Conditions
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Femoral Neck Fractures, Hemiarthroplasty, Heterotopic Ossification

Intervention / Treatment
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* Procedure: Hemiarthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 70 and 90 years of age with displaced femoral neck fractures Intact cognitive function Ability to walk with or without a walking aid prior to falling. Exclusion Criteria: Dementia Fractures in pathologic bone Patients not belonging to the hospital community Patients with sepsis or local infection Fracture not eligible to be treated with a hemiarthroplasty

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 90 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: Anterolateral approach<br>Standard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip. | Procedure: Hemiarthroplasty<br>* Radiological features comparing the femoral stem position is measured on the postoperative x-ray. Presence of heterotopic ossification is assessed on the 12 months follow up.<br>|
| Active Comparator: Lateral approach<br>Standard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip. | Procedure: Hemiarthroplasty<br>* Radiological features comparing the femoral stem position is measured on the postoperative x-ray. Presence of heterotopic ossification is assessed on the 12 months follow up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg length | The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head | Immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral offset | The distance between the longitudinal axis of the femur to the centre of the femoral head and the distance from the centre of the femoral head to a perpendicular line passing through the medial edge of the teardrop | Immediately after surgery | 
| Valgus/varus stem position | Stem position in relation to the femoral axis | Immediately after surgery | 
| Heterotopic ossification | Classified as type 1-4 according to Brooker classification | 1 year | 
| Canal fill ratio | Was evaluated at the following points; 2 cm above the lower trochanter, at the tip of the lower trochanter, 2 cm and 7 cm below the tip of lesser trochanter | Immediately after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femoral offset, leg length discrepancy, valgus/varus position, Lateral approach, Anterolateral approach