Functional Outcome After Arthroplasty

Fracture Neck of Femur Clinical Trial

Official title:

Functional Outcome After Dual Mobility Cups Total Hip Replacement Versus Bipolar Hemiarthroplasty in Fracture Neck of Femur in Active Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680572
• Other study ID #: MD thesis protocol
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bipolar hemiarthroplasty (BA) has long been the preferred treatment and is performed in most fracture neck of femur (FNF) cases. It is justified by the reasonable operative time, low blood loss and acceptable functional outcomes. The dual mobility cup total hip replacement (DMTHA) has emerged as a relevant alternative to BA. Since then, there is an on-going debate on the best implant to use. Age, co-morbidities, patient independence and potential surgical complications must be considered when deciding between implants. The risk of dislocation is a crucial factor because of its important consequences. The investigators evaluated the functional and mechanical outcomes of BA versus DMTHA in FNF in active elderly patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 30, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• active patients
• displaced fracture neck of femur
• age from 60 to 80

Exclusion Criteria:

• ipsilateral previous hip surgery
• grade 3 hip osteoarthritis according to tonnis classifiction
• dysplastic acetabulum

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fracture Neck of Femur

Intervention

Procedure:
• arthroplasty
arthroplasty for fracture neck of femur

Locations

Country	Name	City	State
Egypt	Ain Shams university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional outcome using the Harris hip score	hip joint range of motion and activities of daily living	2 years
Primary	rate of dislocation	postoperative prosthesis dislocation	2 years
Secondary	operative time in minutes	the time needed to perform the procedure	45 minutes to 2 hours
Secondary	blood loss in cc	the amount of blood loss during the procedure	during the procedure