Outcome of Total Hip Replacement in Patients With Chronic Renal Disease

May 9, 2018 updated by: MBMady, Assiut University
the study aims to determine rate of mortality and morbidity after total hip replacement in patients with chronic kidney diseases and incidence of periprosthetic joint infection in these patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Retrospective review of the database of arthroplasty unit was conducted from January 2014 to December 2018. Data of all patients who suffered from chronic kidney disease and underwent hip arthroplasty because of fracture neck of femur or arthritis or head necrosis or any other cause , will be collected as, Demographic characteristics: age , gender , place of residence and diagnosis. Medical comorbidities: other comorbidities will be taken in consideration as Diabetes, Hypertension and cardiac problems.

Detailed history of patient's renal disease: cause of renal disease ,duration of the renal disease , grading of renal failure according to National Kidney Foundation (NKF) guidelines , medical treatment : whether the patient is on regular medical treatment or not, duration of medical treatment and type of medications and dialysis history : whether the patient is dialysis dependant or not, duration of being dialysis dependant and frequency of dialysis.

Post operative surgical complications as : dislocation, infection , periprosthetic fracture or loosing and osteolysis.

Post operative medical complications as : myocardial infarction , stroke , pulmonary embolism and deep venous thrombosis.

At Follow up :

Clinical assessment will be done for signs of infection as hotness , redness, tenderness and discharge from wound site.

Functional assessment also will be done , it will be done by Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS) and The 12-Item Short Form Survey (SF-12).

Radiological assessment also will be done for signs of loosing as lucency and component migration and for signs of infection as periosteal reaction , irregular osteolysis , absence of sclerotic border and cortical bone resorption .

Investigations for periprosthetic infection will be carried out: erythrocyte sedimentation rate (ESR), C- reactive protein (CRP) and complete blood count (CBC) to predict presence of infection , if they are positive , aspiration will be carried out to know type of organism.

If there is past definite history of infection, detailed data will be recorded as:

Time of presence of infection from surgery and result of culture and sensitivity ( if was done) to know the type of the organism,type of treatment done(whatever medical or surgical treatment) and frequency of infection recurrence.

Also history of revision surgery , rate and its causes will be recorded.

Those patients will be divided into two groups, one group is that group of chronic renal disease patients who were on regular dialysis at time of operation and the other is that group who were not dialysis dependant at time of operation . rate of each complication of the previously mentioned complications, will be calculated in the two groups . Results will show which group is at higher risk of complications of the two groups .

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic renal diseases who underwent total hip replacement surgery from January 2014 to December 2017

Description

Inclusion Criteria:

  1. patients with chronic renal disease who had total hip arthroplasty .
  2. Patients underwent hip arthroplasty between January 2014 to December 2017 in Assiut University Hospital

Exclusion Criteria:

No patients will be excluded

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morbidity and mortality after total hip replacement in patients with chronic kidney disease
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of periprosthetic infection after total hip replacement in patients with chronic renal diseases; dialysis dependant and non- dependant
Time Frame: one year
rate of incidence of periprosthetic infection after total hip replacement in patients with chronic renal diseases, frequency of recurrence of infection and if dialysis dependency increase risk of infection
one year

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)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

April 28, 2018

First Submitted That Met QC Criteria

May 9, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hip arthroplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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