Functional Outcome After Arthroplasty

NCT04680572 | Completed

• 1 other identifier: MD thesis protocol
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fracture Neck of Femur

Outcome Measures

Primary Outcomes (2)

• functional outcome using the Harris hip score

  hip joint range of motion and activities of daily living

  2 years

• rate of dislocation

  postoperative prosthesis dislocation

  2 years

Secondary Outcomes (2)

• operative time in minutes

  45 minutes to 2 hours

• blood loss in cc

  during the procedure

Study Arms (2)

Bipolar hemiarthroplasty group

ACTIVE COMPARATOR

Procedure: arthroplasty

Dual mobility cups total hip replacement group

ACTIVE COMPARATOR

Procedure: arthroplasty

Interventions

arthroplasty PROCEDURE

arthroplasty for fracture neck of femur

Bipolar hemiarthroplasty group; Dual mobility cups total hip replacement group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Arthroplasty

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Ibrahim M Ganzoury, professor

  Faculty of Medicine Ain Shams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 23, 2020
• Study Start: January 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 30, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)