Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Location contact
Anna Tarasiuk
CONTACT
Stijn Ghijselings
PRINCIPAL_INVESTIGATOR
Stijn Ghijselings, Dr.
CONTACT
NCT Number: NCT07481448
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.
Interested in participating?
Request InfoAll sexes
Observational
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Anna Tarasiuk
CONTACT
Stijn Ghijselings
PRINCIPAL_INVESTIGATOR
Stijn Ghijselings, Dr.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrollment to the end of the study, following 30 years of follow-up
Time frame: From enrollment to the end of the study, following 30 years of follow-up
Time frame: From enrollment to the end of the study, following 30 years of follow-up
Time frame: From enrollment to the end of the study, following a 30-year follow-up period
Time frame: From enrollment to the end of the study, following a 30-year follow-up period
Time frame: From enrollment to the end of the study, following a 30-year follow-up period
Time frame: At the time of enrollment
Recorded in days
Time frame: From enrollment to the end of the study, following a 30-year follow-up period
This 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").
Time frame: From enrollment to the end of the study, following a 30-year follow-up period
To 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."
Time frame: From enrollment to the end of the study, following a 30-year follow-up period
The 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.
Time frame: From enrollment to the end of the study, following a 30-year follow-up period
The 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.
Time frame: At the time of enrollment
Number of patient readmissions to the hospital following (aseptic revision) THA
Time frame: From enrollment to the end of the study, following a 30-year follow-up period
All-cause mortality during the study follow-up period
Contact information is provided by the study sponsor or research team.
Anna Tarasiuk
CONTACT
Stijn Ghijselings, Dr.
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
Long-term Follow-up of Patients Undergoing Aseptic Revision Hip Arthroplasty or Complex Primary Hip Arthroplasty Treated at University Hospitals Leuven
Acronym: LARA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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