Long-term Follow-up of Patients Undergoing Aseptic Revision Hip Arthroplasty or Complex Primary Hip Arthroplasty Treated at University Hospitals Leuven
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of revision surgeries performed for any reason
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
结局指标
主要结局
Number of revision surgeries performed for any reason
时间窗: From enrollment to the end of the study, following 30 years of follow-up
次要结局
- Length of hospital stay for (aseptic revision) THA(At the time of enrollment)
- 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)
- Number of patient readmissions(At the time of enrollment)
- Questionnaire about living situation(From enrollment to the end of the study, following a 30-year follow-up period)
- EQ-5D-5L health questionnaire(From enrollment to the end of the study, following a 30-year follow-up period)
- Hip disability and Osteoarthritis Outcome Score (HOOS)(From enrollment to the end of the study, following a 30-year follow-up period)
- Oxford Hip Score(From enrollment to the end of the study, following a 30-year follow-up period)
- Mortality rates(From enrollment to the end of the study, following a 30-year follow-up period)