NCT03522285

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

April 28, 2018

Last Update Submit

May 9, 2018

Conditions

Arthroplasty Complications

Keywords

hip arthroplastychronic renal diseases

Outcome Measures

Primary Outcomes (1)

  • Morbidity and mortality after total hip replacement in patients with chronic kidney disease

    one year

Secondary Outcomes (1)

  • Incidence of periprosthetic infection after total hip replacement in patients with chronic renal diseases; dialysis dependant and non- dependant

    one year

Interventions

investigation: erythrocyte sedimentation rateOTHER

investigations will be done to detect presence of infection and x-ray also for detection of infection or loosing of hip components

Also known as: radiation: x-ray, investigation: C reactive protein, investigation: complete blood count

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No patients will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 9820460BACKGROUND

  • Ayers DC, Athanasou NA, Woods CG, Duthie RB. Dialysis arthropathy of the hip. Clin Orthop Relat Res. 1993 May;(290):216-24.

    PMID: 8472452BACKGROUND

  • Tejwani 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.

    PMID: 16675624BACKGROUND

  • DiRaimondo 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.

    PMID: 3703063BACKGROUND

  • 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.

    PMID: 7587515BACKGROUND

  • 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.

    PMID: 21037348BACKGROUND

  • Deo 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.

    PMID: 7706352BACKGROUND

  • Bradford DS, Janes PC, Simmons RS, Najarian JS. Total hip arthroplasty in renal transplant recipients. Clin Orthop Relat Res. 1983 Dec;(181):107-14.

    PMID: 6357584BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Michael B. Mady, M.B.B.ch

CONTACT

01004880799michael24792@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident of orthopedics and trauma surgery

Study Record Dates

First Submitted

April 28, 2018

First Posted

May 11, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2019

Study Completion

October 1, 2019

Last Updated

May 11, 2018

Record last verified: 2018-05