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Completed

NCT Number: NCT02028468

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

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.

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Key information

Conditions

Femoral Neck Fracture Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

70 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sorlandet Hospital

Kristiansand, 4604, Norway

About this study

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.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients 70- 85 Years of Age -

Exclusion criteria

Dementia, Infection Not Suitable for Hemiarthroplasty

-

Treatment and study plan

Hemiarthroplasty

Procedure

Primary outcomes

  1. Visual Analogue Scale Pain and Patient Satisfaction

    Time frame: Pre and postoperative, 3 and 12 Months

Secondary outcomes

  1. Timed up and go

    Time frame: postoperative, 3 and 12 Monthes

    TUG test- Timed up and Go

  2. Harris Hip Score

    Time frame: Pre / Postoperative, 3 and 12 Months

  3. Hip Osteoarthritis Disability Score

    Time frame: Postoperative, 3 and 12 Months

  4. EuroQol

    Time frame: Postoperative, 3 and 12 Months

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2022
First posted
Jan 7, 2014
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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