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Long-term Aseptic Revision & Advanced Hip Arthroplasty Database

Long-term Follow-up of Patients Undergoing Aseptic Revision Hip Arthroplasty or Complex Primary Hip Arthroplasty Treated at University Hospitals Leuven

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07481448
Acronym
LARA
Enrollment
200
Registered
2026-03-18
Start date
2026-07-01
Completion date
2037-03-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthropathy Associated With Other Conditions

Brief summary

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.

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients undergoing a hip replacement for the following indications: 1. THA with hardware removal 2. THA for hip dysplasia 3. THA with femoral deformity or prior corrective surgery 4. THA after LCPD, SCFE or septic arthritis 5. THA in metabolic disease 6. THA in hyperlaxity (e.g. Ehlers-Danlos syndrome, Down syndrome) 7. THA with complex bony anatomy 8. THA in patients aged 25 years or younger 9. 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.

Design outcomes

Primary

MeasureTime frame
Number of revision surgeries performed for any reasonFrom enrollment to the end of the study, following 30 years of follow-up

Secondary

MeasureTime frameDescription
Number of revision for aseptic looseningFrom enrollment to the end of the study, following 30 years of follow-up
Number of revision for periprosthetic joint infections (PJI) DislocationFrom enrollment to the end of the study, following 30 years of follow-up
Overview of different treatments for periprosthetic fracturesFrom enrollment to the end of the study, following a 30-year follow-up period
Overview of surgical complicationsFrom enrollment to the end of the study, following a 30-year follow-up period
Overview of medical complicationsFrom enrollment to the end of the study, following a 30-year follow-up period
Length of hospital stay for (aseptic revision) THAAt the time of enrollmentRecorded in days
Questionnaire about living situationFrom enrollment to the end of the study, following a 30-year follow-up periodThis questionnaire provides a general overview of the patient's living situation - Does patient lives alone or with someone else (children, partner, others) - What type of property (Homeless, house, appartment,...). the questionnaire assesses the use of home care support and specifies the types of assistance required if such support is present (answer is "Yes").
EQ-5D-5L health questionnaireFrom enrollment to the end of the study, following a 30-year follow-up periodTo evaluate mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Every topic can be answered with "No", "Slight", "moderate", "severe", "not able to/Extreme". Additionally, patients provide a self-assessment of their overall health using a Visual Analogue Scale (VAS) from 0 to 100, where 0 represents the "worst health imaginable" and 100 represents the "best health imaginable."
Hip disability and Osteoarthritis Outcome Score (HOOS)From enrollment to the end of the study, following a 30-year follow-up periodThe Hip Disability and Osteoarthritis Outcome Score (HOOS) is a structured questionnaire designed to evaluate the symptoms and limitations experienced by patients with hip conditions, particularly osteoarthritis. The HOOS consists of 40 items divided into five subscales: Symptoms (including stiffness), Pain, Activities of Daily Living (ADL), Sport and Recreation Function, and Hip-related Quality of Life (QOL). Each item is rated on a 5-point Likert scale (0-4). The subscale scores are transformed to a 0-100 scale, where 0 represents extreme hip problems and 100 represents no hip problems.
Oxford Hip ScoreFrom enrollment to the end of the study, following a 30-year follow-up periodThe Oxford Hip Score (OHS) is a short 12-item survey, where each item has five possible responses. Patients are asked to reflect on their pain and functional ability over the past four weeks. Responses are typically scored from 0 to 4 (where 4 represents the best outcome) or 1 to 5. When using the 1-5 scale, item scores are summed to give a total score between 12 and 60. In this specific scoring system, a lower score indicates a better clinical outcome.
Number of patient readmissionsAt the time of enrollmentNumber of patient readmissions to the hospital following (aseptic revision) THA
Mortality ratesFrom enrollment to the end of the study, following a 30-year follow-up periodAll-cause mortality during the study follow-up period

Countries

Belgium

Contacts

CONTACTStijn Ghijselings, Dr.
stijn.ghijselings@uzleuven.be+32 16 33 88 72
CONTACTAnna Tarasiuk
orthopedie.research@uzleuven.be+32 16 33 88 18
PRINCIPAL_INVESTIGATORStijn Ghijselings, Dr.

UZ Leuven

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026