Long-term Aseptic Revision & Advanced Hip Arthroplasty Database
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hip Arthropathy Associated With Other Conditions. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Follow-up of Patients Undergoing Aseptic Revision Hip Arthroplasty or Complex Primary Hip Arthroplasty Treated at University Hospitals Leuven
Overview
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.
Detailed description
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, including developmental dysplasia, avascular necrosis, post-traumatic deformities, and sequelae of childhood diseases such as femoro-acetabular impingement, septic arthritis, Legg-Calvé-Perthes disease, and slipped capital femoral epiphysis.
As a result, the number of revision procedures is growing and is expected to increase further. Two distinct patient groups drive this trend. First, individuals who received a primary THA in their 60s or 70s frequently require revision in their 80s or 90s, where reduced physiological reserve and multiple comorbidities create specific perioperative challenges. Second, patients who undergo THA at a young age - often due to congenital or childhood pathology - have a long life expectancy and a higher probability of needing revision surgery later on.
University Hospitals Leuven receive a substantial share of these complex cases, given our expertise in complex primary and revision hip arthroplasty and our multidisciplinary, patient-tailored approach.
However, the heterogeneity of these patients - due to varying indications, implant types, bone defects, and previous procedures - makes randomized controlled trials in this field difficult to conduct. Consequently, many clinical questions remain unresolved.
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.
Primary outcome measures
- Number of revision surgeries performed for any reason [Time frame: From enrollment to the end of the study, following 30 years of follow-up]
Secondary outcome measures (12)
- Number of revision for aseptic loosening [Time frame: From enrollment to the end of the study, following 30 years of follow-up]
- Number of revision for periprosthetic joint infections (PJI) Dislocation [Time frame: From enrollment to the end of the study, following 30 years of follow-up]
- Overview of different treatments for periprosthetic fractures [Time frame: From enrollment to the end of the study, following a 30-year follow-up period]
- Overview of surgical complications [Time frame: From enrollment to the end of the study, following a 30-year follow-up period]
- Overview of medical complications [Time frame: From enrollment to the end of the study, following a 30-year follow-up period]
- Length of hospital stay for (aseptic revision) THA [Time frame: At the time of enrollment]
- Questionnaire about living situation [Time frame: From enrollment to the end of the study, following a 30-year follow-up period]
- EQ-5D-5L health questionnaire [Time frame: From enrollment to the end of the study, following a 30-year follow-up period]
- Hip disability and Osteoarthritis Outcome Score (HOOS) [Time frame: From enrollment to the end of the study, following a 30-year follow-up period]
- Oxford Hip Score [Time frame: From enrollment to the end of the study, following a 30-year follow-up period]
- Number of patient readmissions [Time frame: At the time of enrollment]
- Mortality rates [Time frame: From enrollment to the end of the study, following a 30-year follow-up period]
Eligibility criteria
Inclusion criteria
- Patients undergoing a hip replacement for the following indications:
- THA with hardware removal
- THA for hip dysplasia
- THA with femoral deformity or prior corrective surgery
- THA after LCPD, SCFE or septic arthritis
- THA in metabolic disease
- THA in hyperlaxity (e.g. Ehlers-Danlos syndrome, Down syndrome)
- THA with complex bony anatomy
- THA in patients aged 25 years or younger
- Other indications for which the treating surgeon expects increased surgical difficulty or increased risk of postoperative complications
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Universitaire Ziekenhuizen KU Leuven — Leuven
Identifiers
NCT: NCT07481448 · S71716