Arthroplasty ComplicationsNCT03522285
Outcome of Total Hip Replacement in Patients With Chronic Renal Disease
An observational study of Arthroplasty Complications, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- investigation: erythrocyte sedimentation rate
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic renal diseases who underwent total hip replacement surgery from January 2014 to December 2017
Who may be able to join
- patients with chronic renal disease who had total hip arthroplasty .
- Patients underwent hip arthroplasty between January 2014 to December 2017 in Assiut University Hospital
Who cannot join
- No patients will be excluded
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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 .
- Conditions
- Arthroplasty Complications
- Being tested
- investigation: erythrocyte sedimentation rate
- Keywords
- hip arthroplasty, chronic renal diseases
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigation: erythrocyte sedimentation rateOther
Also called radiation: x-ray, investigation: C reactive protein, investigation: complete blood count
investigations will be done to detect presence of infection and x-ray also for detection of infection or loosing of hip components
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity and mortality after total hip replacement in patients with chronic kidney disease
Measured: one year
Secondary outcomes (1)
Incidence of periprosthetic infection after total hip replacement in patients with chronic renal diseases; dialysis dependant and non- dependant
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MBMady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522285
- Sponsor's protocol ID
- hip arthroplasty
- Status last verified
- May 2018
- First submitted
- 28 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Levey AS, Beto JA, Coronado BE, Eknoyan G, Foley RN, Kasiske BL, Klag MJ, Mailloux LU, Manske CL, Meyer KB, Parfrey PS, Pfeffer MA, Wenger NK, Wilson PW, Wright JT Jr. Controlling the epidemic of cardiovascular disease in chronic renal disease: what do we know? What do we need to learn? Where do we go from here? National Kidney Foundation Task Force on Cardiovascular Disease. Am J Kidney Dis. 1998 Nov;32(5):853-906. doi: 10.1016/s0272-6386(98)70145-3. No abstract available.
PubMed 9820460Ayers DC, Athanasou NA, Woods CG, Duthie RB. Dialysis arthropathy of the hip. Clin Orthop Relat Res. 1993 May;(290):216-24.
PubMed 8472452Tejwani NC, Schachter AK, Immerman I, Achan P. Renal osteodystrophy. J Am Acad Orthop Surg. 2006 May;14(5):303-11. doi: 10.5435/00124635-200605000-00006.
PubMed 16675624DiRaimondo CR, Casey TT, DiRaimondo CV, Stone WJ. Pathologic fractures associated with idiopathic amyloidosis of bone in chronic hemodialysis patients. Nephron. 1986;43(1):22-7. doi: 10.1159/000183712.
PubMed 3703063Gualtieri 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.
PubMed 7587515McCleery 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.
PubMed 21037348Deo S, Gibbons CL, Emerton M, Simpson AH. Total hip replacement in renal transplant patients. J Bone Joint Surg Br. 1995 Mar;77(2):299-302.
PubMed 7706352Bradford DS, Janes PC, Simmons RS, Najarian JS. Total hip arthroplasty in renal transplant recipients. Clin Orthop Relat Res. 1983 Dec;(181):107-14.
PubMed 6357584
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Total Hip Replacement in Patients With Chronic Renal Disease
- ClinicalTrials.gov ID
- NCT03522285
- Acronym / sponsor ID
- hip arthroplasty
- Conditions
- Arthroplasty Complications
- Keywords
- hip arthroplasty, chronic renal diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic renal diseases who underwent total hip replacement surgery from January 2014 to December 2017
Key inclusion criteria (2 listed)
- patients with chronic renal disease who had total hip arthroplasty .
- Patients underwent hip arthroplasty between January 2014 to December 2017 in Assiut University Hospital
Key exclusion criteria (1 listed)
- No patients will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| investigation: erythrocyte sedimentation rateAlso: radiation: x-ray, investigation: C reactive protein, investigation: complete blood countinvestigations will be done to detect presence of infection and x-ray also for detection of infection or loosing of hip components | Other | – |
Primary outcome
Morbidity and mortality after total hip replacement in patients with chronic kidney disease
Time frame: one year
1 secondary outcome
Incidence of periprosthetic infection after total hip replacement in patients with chronic renal diseases; dialysis dependant and non- dependant
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 9820460Levey AS, Beto JA, Coronado BE, Eknoyan G, Foley RN, Kasiske BL, Klag MJ, Mailloux LU, Manske CL, Meyer KB, Parfrey PS, Pfeffer MA, Wenger NK, Wilson PW, Wright JT Jr. Controlling the epidemic of cardiovascular disease in chronic renal disease: what do we know? What do we need to learn? Where do we go from here? National Kidney Foundation Task Force on Cardiovascular Disease. Am J Kidney Dis. 1998 Nov;32(5):853-906. doi: 10.1016/s0272-6386(98)70145-3. No abstract available.
- Background: PubMed 8472452Ayers DC, Athanasou NA, Woods CG, Duthie RB. Dialysis arthropathy of the hip. Clin Orthop Relat Res. 1993 May;(290):216-24.
- Background: PubMed 16675624Tejwani NC, Schachter AK, Immerman I, Achan P. Renal osteodystrophy. J Am Acad Orthop Surg. 2006 May;14(5):303-11. doi: 10.5435/00124635-200605000-00006.
- Background: PubMed 3703063DiRaimondo CR, Casey TT, DiRaimondo CV, Stone WJ. Pathologic fractures associated with idiopathic amyloidosis of bone in chronic hemodialysis patients. Nephron. 1986;43(1):22-7. doi: 10.1159/000183712.
- Background: PubMed 7587515Gualtieri 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.
- Background: PubMed 21037348McCleery 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.
- Background: PubMed 7706352Deo S, Gibbons CL, Emerton M, Simpson AH. Total hip replacement in renal transplant patients. J Bone Joint Surg Br. 1995 Mar;77(2):299-302.
- Background: PubMed 6357584Bradford DS, Janes PC, Simmons RS, Najarian JS. Total hip arthroplasty in renal transplant recipients. Clin Orthop Relat Res. 1983 Dec;(181):107-14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty Complications, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B. Mady, M.B.B.ch (01004880799, michael24792@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity and mortality after total hip replacement in patients with chronic kidney disease (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03522285, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.