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

NCT ID: NCT02028468

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2022-03-11

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

Conditions

Femoral Neck Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Anterolateral Approach

Patient Operated with Watson Jones Approach

Group Type: ACTIVE_COMPARATOR

hemiarthroplasty

Intervention Type: PROCEDURE

Trans-gluteal Approach

Patient operated with Trans-gluteal Hardinge Approach

Group Type: ACTIVE_COMPARATOR

hemiarthroplasty

Intervention Type: PROCEDURE

Interventions

hemiarthroplasty

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

Dementia, Infection Not Suitable for Hemiarthroplasty

-

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Nordsletten, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Oslo Ullevål

Locations

Sorlandet Hospital

Kristiansand, , Norway

Countries

Norway

References

Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22.

Reference Type: DERIVED

PMID: 29789919 (View on PubMed)

Other Identifiers

811419

Identifier Type: -

Identifier Source: org_study_id