Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture

Not Applicable

Completed

• Conditions: Femoral Neck Fracture
• Interventions: Procedure: hemiarthroplasty

• Registration Number: NCT02028468
• Lead Sponsor: Sorlandet Hospital HF

Brief Summary

Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.

Detailed Description

The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.

The study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.

1. A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.

2. A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach

Study Timeline

• Study First Submitted: 2014-01-03
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-07
• Study Start: 2014-02
• Primary Completion: 2018-03
• Status Verified: 2022-03
• Study Completion: 2022-03-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

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

Inclusion Criteria

Patients 70- 85 Years of Age -

Exclusion Criteria

Dementia, Infection Not Suitable for Hemiarthroplasty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-gluteal Approach	hemiarthroplasty	Patient operated with Trans-gluteal Hardinge Approach
Anterolateral Approach	hemiarthroplasty	Patient Operated with Watson Jones Approach

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale Pain and Patient Satisfaction	Pre and postoperative, 3 and 12 Months

Secondary Outcome Measures

Name	Time	Method
Timed up and go	postoperative, 3 and 12 Monthes	TUG test- Timed up and Go
EuroQol	Postoperative, 3 and 12 Months
Harris Hip Score	Pre / Postoperative, 3 and 12 Months
Hip Osteoarthritis Disability Score	Postoperative, 3 and 12 Months

Trial Locations

Locations (1)

Sorlandet Hospital; 🇳🇴 Kristiansand, Norway