Clinical trial NCT03522285: Outcome of Total Hip Replacement in Patients With Chronic Renal Disease
Official title: Outcome of Total Hip Replacement in Patients With Chronic Renal Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthroplasty Complications
Keywords: hip arthroplasty
chronic renal diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic renal diseases who underwent total hip replacement surgery from January 2014 to December 2017

Brief summary: 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.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Morbidity and mortality after total hip replacement in patients with chronic kidney disease
timeFrame: one year
Secondary outcomes:
measure: Incidence of periprosthetic infection after total hip replacement in patients with chronic renal diseases; dialysis dependant and non- dependant
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
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citation: Gualtieri G, Vellani G, Dallari D, Catamo L, Gualtieri I, Fatone F, Bonomini V. Total hip arthroplasty in patients dialyzed or with renal transplants. Chir Organi Mov. 1995 Apr-Jun;80(2):139-45. English, Italian.
citation: McCleery MA, Leach WJ, Norwood T. Rates of infection and revision in patients with renal disease undergoing total knee replacement in Scotland. J Bone Joint Surg Br. 2010 Nov;92(11):1535-9. doi: 10.1302/0301-620X.92B11.23870.
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citation: Bradford DS, Janes PC, Simmons RS, Najarian JS. Total hip arthroplasty in renal transplant recipients. Clin Orthop Relat Res. 1983 Dec;(181):107-14.