Long-term Aseptic Revision & Advanced Hip Arthroplasty Database
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Total hip arthroplasty (THA) volumes continue to rise each year as the population ages and indications broaden. Increasingly, younger patients require hip replacement for conditions beyond primary osteoarthritis or fractures. As a result, the number of revision procedures is growing and is expected to increase further.
Prospective data collection within this population will enable us to address key uncertainties, particularly around optimal implant selection for complex primary and revision cases.
In addition, establishing a structured prospective database will allow for systematic internal auditing for quality assurance. Even simple metrics - such as verifying whether every patient received a complete diagnostic infection workup before revision surgery - could immediately enhance service quality and inform improvements to clinical pathways.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
THA with hardware removal
THA for hip dysplasia
THA with femoral deformity or prior corrective surgery
THA after LCPD, SCFE or septic arthritis
Disqualifiers
Patients unable to provide written informed consent
Patients who prefer treatment outside of University Hospitals Leuven
Patients with proven PJI according to the 2021 EBJIS criteria
Patients undergoing standard, non-complex, hip replacement as judged by the treating physician.
Trial population
Every patient, regardless of sex or age, undergoing complex primary THA or aseptic revision hip arthroplasty, is eligible for inclusion in this study. This study will therefore also include children and women of childbearing age, although this is expected to be extremely rare. The decision on whether a primary hip replacement is categorized as a complex procedure is left to the discretion of the treating physician.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Complex primary Total Hip Arthroplasty
Group B: Aseptic revision Total Hip Arhtroplasty
Trial outcomes
Primary outcomes
1
Number of revision surgeries performed for any reason
Time frame
From enrollment to the end of the study, following 30 years of follow-upSecondary outcomes
1
Number of revision for aseptic loosening
Time frame
From enrollment to the end of the study, following 30 years of follow-up2
Number of revision for periprosthetic joint infections (PJI) Dislocation
Time frame
From enrollment to the end of the study, following 30 years of follow-up3
Overview of different treatments for periprosthetic fractures
Time frame
From enrollment to the end of the study, following a 30-year follow-up period4
Overview of surgical complications
Time frame
From enrollment to the end of the study, following a 30-year follow-up periodSponsors and contacts
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Source ClinicalTrials.gov