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Outcome of Total Hip Replacement in Patients With Chronic Renal Disease

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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
Sponsor:
Information provided by (Responsible Party):
MBMady, Assiut University

Tracking Information
First Submitted Date April 28, 2018
First Posted Date May 11, 2018
Last Update Posted Date May 11, 2018
Estimated Study Start Date June 1, 2018
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2018)
Morbidity and mortality after total hip replacement in patients with chronic kidney disease [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 9, 2018)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcome of Total Hip Replacement in Patients With Chronic Renal Disease
Official Title Outcome of Total Hip Replacement in Patients With Chronic Renal Disease
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 .

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with chronic renal diseases who underwent total hip replacement surgery from January 2014 to December 2017
Condition Arthroplasty Complications
Intervention 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 components
Other Names:
  • radiation: x-ray
  • investigation: C reactive protein
  • investigation: complete blood count
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 9, 2018)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03522285
Other Study ID Numbers hip arthroplasty
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party MBMady, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date May 2018