Clinical Trial on Hip Arthropathy - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Hip Arthropathy

Detailed Description

Neck of femur fractures are occurring at an increased incidence, Functionally independent patients without cognitive impairment can expect reasonable life expectancy, this indicates the need for a durable surgical option that optimises the chance to return to pre-injury functional status, with minimal risk of complications and reoperation. THA should be considered the gold standard producing better functional and quality of life outcomes lower reoperation rates and better cost effectiveness.

THA is associated with better functional outcomes and a lower risk of revision surgery in self-sufficient, physically active patients , Instability is the leading complication of conventional THA and occurs with a higher incidence ,THA remains the option of choice as it provides better functional outcomes.

Although the clinical outcomes of total hip arthroplasty (THA) in elderly patients with femoral neck fracture were reported to be better than hemiarthroplasty, hemiarthroplasty was frequently recommended in cases where the patient has a low functional level and/or osteoporosis and high rates of postoperative dislocation of total hip arthroplasty.

Hip joint replacement surgery is considered one of the most successful operations due to its high success and low complication rate , one possible risk factor for early failure of total hip arthroplasty (THA) is the subsidence of the femoral stem , Cementless THA in particular could be susceptible to subsidence.

Cementless femoral stems ideally achieve direct integration between the stem surface and endosteal bone with the aim of decreasing the incidence of aseptic loosening.

Subsidence is defined as a distalization of the femoral stem in reference to the greater trochanter.

Measurement of subsidence of uncemented femoral stems can be used to evaluate the likelihood of long term stem component loosening and therefore clinical failure .

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Amgad Rasmy Moreed Gerges, fellow
Phone Number: 01205302836
Email: Amgad.20133877@med.aun.edu.eg

Study Contact Backup

Name: Mohamed Moustafa Alaa Eldin Abdel-Aziz, PhD
Phone Number: 01096967747
Email: mohamed.m.alaa@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cases that previously underwent cementless hip arthroplasty for fracture neck of femur at arthroplasty unit at assiut university hospital.

Description

Inclusion Criteria:

cases that underwent cementless hip arthroplasty for fracture neck of femur

Exclusion Criteria:

- 1- malignancy. 2- Previous plating. 3- Revision for infection. 4- dysplasia. 5- SLE and Rheumatoid Arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur. Time Frame: an average of 1 year post operatively	Radiological evaluation of stem subsidence by standing anteroposterior radiograph on hip joint 1 year post-operatively to be compared with the previous anteroposterior hip radiograph that was done immediately after operation and assessment of subsidence by measuring the distance between the apex of major trochanter and the stem shoulder or measuring the distance between stem shoulder of hip prosthesis and the most prominent point of lesser trochanter	an average of 1 year post operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
1- Harris Hip Scoring for assessment pain and distance walked and range of motion and quality of life. 2- Health Survey (SF-36) Scoring.foe assesment of health ststus and daily activities 3- Any complications detected. Time Frame: 1 year after surgery.	1 year after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Estimate)

January 4, 2023

Study Record Updates

Last Update Posted (Estimate)