Hip Arthropathy Associated With Other ConditionsLARANCT07481448
Long-term Aseptic Revision & Advanced Hip Arthroplasty Database
An observational study of Hip Arthropathy Associated With Other Conditions, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Arthropathy Associated With Other Conditions
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2026to Mar 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, 3000
Stijn Ghijselings, Dr., +32 16 34 08 88, stijn.ghijselings@uzleuven.be
Anna Tarasiuk, +32 16 33 88 18, orthopedie.research@uzleuven.be
About this study
Official title: Long-term Follow-up of Patients Undergoing Aseptic Revision Hip Arthroplasty or Complex Primary Hip Arthroplasty Treated at University Hospitals Leuven
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Complex primary Total Hip Arthroplasty | Complex primary Total Hip Arthroplasty, where the decision whether a primary hip replacement is categorized as a complex procedure is left to the discretion of the treating physician | |
| Aseptic revision Total Hip Arhtroplasty | Periprosthetic joint infection excluded based on the EBJIS 2021 criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of revision surgeries performed for any reason
Measured: From enrollment to the end of the study, following 30 years of follow-up
Secondary outcomes (12)
Number of revision for aseptic loosening
Measured: From enrollment to the end of the study, following 30 years of follow-up
Number of revision for periprosthetic joint infections (PJI) Dislocation
Measured: From enrollment to the end of the study, following 30 years of follow-up
Overview of different treatments for periprosthetic fractures
Measured: From enrollment to the end of the study, following a 30-year follow-up period
Overview of surgical complications
Measured: From enrollment to the end of the study, following a 30-year follow-up period
Overview of medical complications
Measured: From enrollment to the end of the study, following a 30-year follow-up period
Length of hospital stay for (aseptic revision) THA
Recorded in days
Measured: At the time of enrollment
Questionnaire about living situation
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").
Measured: From enrollment to the end of the study, following a 30-year follow-up period
EQ-5D-5L health questionnaire
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."
Measured: From enrollment to the end of the study, following a 30-year follow-up period
Hip disability and Osteoarthritis Outcome Score (HOOS)
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.
Measured: From enrollment to the end of the study, following a 30-year follow-up period
Oxford Hip Score
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.
Measured: From enrollment to the end of the study, following a 30-year follow-up period
Number of patient readmissions
Number of patient readmissions to the hospital following (aseptic revision) THA
Measured: At the time of enrollment
Mortality rates
All-cause mortality during the study follow-up period
Measured: From enrollment to the end of the study, following a 30-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startJul 2026 (estimated)
- Primary completionMar 2037 (estimated)
- Study completionMar 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Arthropathy Associated With Other ConditionsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stijn Ghijselings, Dr., Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481448
- Sponsor's protocol ID
- S71716
- Acronym
- LARA
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Patients Undergoing Aseptic Revision Hip Arthroplasty or Complex Primary Hip Arthroplasty Treated at University Hospitals Leuven
- ClinicalTrials.gov ID
- NCT07481448
- Acronym / sponsor ID
- LARA / S71716
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2037 (estimated)
- Study completion
- Mar 2037 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex primary Total Hip Arthroplasty | – | –Complex primary Total Hip Arthroplasty, where the decision whether a primary hip replacement is categorized as a complex procedure is left to the discretion of the treating physician |
| Aseptic revision Total Hip Arhtroplasty | – | –Periprosthetic joint infection excluded based on the EBJIS 2021 criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (10 listed)
- Patients undergoing a hip replacement for the following indications:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of revision surgeries performed for any reason
Time frame: From enrollment to the end of the study, following 30 years of follow-up
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hip Arthropathy Associated With Other Conditions
Not yet recruitingObservational study
Long-term Survival of THA After Pelvic and/or Femoral Osteotomy
Hip Arthropathy Associated With Other Conditions, Hip Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stijn Ghijselings, Dr. principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy Associated With Other Conditions, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stijn Ghijselings, Dr. (+32 16 33 88 72, stijn.ghijselings@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of revision surgeries performed for any reason (time frame: From enrollment to the end of the study, following 30 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.