Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

Sorlandet Hospital HF150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Femoral Neck Fractures Hemiarthroplasty Heterotopic Ossification

Interventions

HemiarthroplastyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 70 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Sorlandet Hospital

Kristiansand, Norway

Outcomes

Primary Outcomes

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

Time frame: Immediately after surgery

Secondary Outcomes

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

Time frame: Immediately after surgery

Valgus/varus stem position

Stem position in relation to the femoral axis

Time frame: Immediately after surgery

Heterotopic ossification

Classified as type 1-4 according to Brooker classification

Time frame: 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

Time frame: Immediately after surgery

Data from ClinicalTrials.gov

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