Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

Not Applicable

Completed

• Conditions: Hemiarthroplasty; Heterotopic Ossification; Femoral Neck Fractures
• Interventions: Procedure: Hemiarthroplasty

• Registration Number: NCT03974698
• Lead Sponsor: Sorlandet Hospital HF

Brief Summary

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

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 Timeline

• Study Start: 2014-02-01
• Primary Completion: 2017-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-05
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-05
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterolateral approach	Hemiarthroplasty	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.
Lateral approach	Hemiarthroplasty	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.

Primary Outcome Measures

Name	Time	Method
Leg length	Immediately after surgery	The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head

Secondary Outcome Measures

Name	Time	Method
Canal fill ratio	Immediately after surgery	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
Valgus/varus stem position	Immediately after surgery	Stem position in relation to the femoral axis
Heterotopic ossification	1 year	Classified as type 1-4 according to Brooker classification
Femoral offset	Immediately after surgery	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

Trial Locations

Locations (1)

Sorlandet Hospital; 🇳🇴 Kristiansand, Norway