Outcome of Total Hip Replacement in Patients With Chronic Renal Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03522285|
Recruitment Status : Unknown
Verified May 2018 by MBMady, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment|
|Arthroplasty Complications||Other: investigation: erythrocyte sedimentation rate|
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|
|Estimated Enrollment :||30 participants|
|Official Title:||Outcome of Total Hip Replacement in Patients With Chronic Renal Disease|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
- Other: investigation: erythrocyte sedimentation rate
investigations will be done to detect presence of infection and x-ray also for detection of infection or loosing of hip componentsOther Names:
- radiation: x-ray
- investigation: C reactive protein
- investigation: complete blood count
- Morbidity and mortality after total hip replacement in patients with chronic kidney disease [ Time Frame: one year ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522285
|Contact: Michael B. Mady, M.B.B.email@example.com|