Long-term Aseptic Revision & Advanced Hip Arthroplasty Database (LARA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Arthropathy Associated With Other Conditions

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Anna Tarasiuk; Phone Number: +32 16 33 88 18; Email: orthopedie.research@uzleuven.be
• Study Contact Backup: Name: Stijn Ghijselings, Dr.; Phone Number: +32 16 33 88 72; Email: stijn.ghijselings@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitaire Ziekenhuizen KU Leuven
      • Contact: Anna Tarasiuk; Phone Number: +32 16 33 88 18; Email: orthopedie.research@uzleuven.be
      • Contact: Stijn Ghijselings, Dr.; Phone Number: +32 16 34 08 88; Email: stijn.ghijselings@uzleuven.be
      • Principal Investigator: Stijn Ghijselings

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Aseptic revision Total Hip Arhtroplasty; Periprosthetic joint infection excluded based on the EBJIS 2021 criteria
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of revision surgeries performed for any reason	From enrollment to the end of the study, following 30 years of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of revision for aseptic loosening		From enrollment to the end of the study, following 30 years of follow-up
Number of revision for periprosthetic joint infections (PJI) Dislocation		From enrollment to the end of the study, following 30 years of follow-up
Overview of different treatments for periprosthetic fractures		From enrollment to the end of the study, following a 30-year follow-up period
Overview of surgical complications		From enrollment to the end of the study, following a 30-year follow-up period
Overview of medical complications		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	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").	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."	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.	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.	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	At the time of enrollment
Mortality rates	All-cause mortality during the study follow-up period	From enrollment to the end of the study, following a 30-year follow-up period

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Stijn Ghijselings, Dr., UZ Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2037
• Study Completion (Estimated): March 1, 2037

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: S71716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No