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

Femoral Neck Fracture Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028468
• Other study ID #: 811419
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: March 11, 2022

Study information

• Verified date: March 2022
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 11, 2022
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

Inclusion Criteria: Patients 70- 85 Years of Age -

Exclusion Criteria:

Dementia, Infection Not Suitable for Hemiarthroplasty

-

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• hemiarthroplasty

Locations

Country	Name	City	State
Norway	Sorlandet Hospital	Kristiansand

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale Pain and Patient Satisfaction		Pre and postoperative, 3 and 12 Months
Secondary	Timed up and go	TUG test- Timed up and Go	postoperative, 3 and 12 Monthes
Secondary	Harris Hip Score		Pre / Postoperative, 3 and 12 Months
Secondary	Hip Osteoarthritis Disability Score		Postoperative, 3 and 12 Months
Secondary	EuroQol		Postoperative, 3 and 12 Months