HAKA: Routine Follow-up at 10 Years After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Number of complications
研究概览
简要总结
After undergoing total hip or total knee arthroplasty, current guidelines recommend routine follow-up with an X-ray within 3 months and again at 1 year. Follow-up at 5 years (for hip arthroplasties) or every 5 years (for knee arthroplasties) is also considered worthwhile according to the guideline. However, these follow-up appointments require considerable time from patients, caregivers, and healthcare professionals, and it is unclear whether they are truly beneficial. It is possible that a single follow-up within 3 months is sufficient. This could potentially prevent over 100,000 unnecessary hospital visits per year, resulting in significant cost savings. If patients or healthcare providers have concerns, they can always request an additional follow-up.
The HAKA trial consists of three different work packages (WPs). This trial (WP2) investigates the 10-year follow-up, WP1 examines the 1-year follow-up, and WP3 is a qualitative study exploring the experiences and perceptions of patients and healthcare professionals. The aim of the HAKA trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Underwent primary THA or TKA approximately 10 years ago
- •Age 50 years or older at time of THA or TKA
- •Capable and willing to complete questionnaires (when applicable)
- •Understanding Dutch or English
- •Willing to provide written informed consent in case the patient will complete questionnaires
排除标准
- •Other indication for surgery than osteoarthritis
- •Revision arthroplasty of hip or knee, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THA
- •Already participating in this study due to another hip or knee surgery
结局指标
主要结局
Number of complications
时间窗: Assessed until 11 years after implantation
The total number of post-operative complications per patient will be recorded.
Type of complications
时间窗: Assessed until 11 years after implantation
Complication types will be recorded and categorized (e.g., infection, periprosthetic fracture, loosening, malalignment, dislocation, prosthetic wear).
Healthcare consumption
时间窗: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.
Healthcare consumption related to THA and TKA FU (number of X-rays and clinical visits)
次要结局
- PROMIS Physical Function(Assessed at 10 and 11 years after implantation)
- Number of surgical interventions(Assessed until 11 years after implantation)
- Type of Surgical Interventions(Assessed until 11 years after implantation)
- Number of additional healthcare consumption(Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.)
- Type of additional healthcare consumption(Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.)
- Costs related to THA or TKA follow-up(Assessed at 10 years after implantation and then after at 3 months, 6 months and 12 months.)
- Numeric Pain Rating Scale (NPRS)(Assessed at 10 and 11 years after implantation)
- Numeric Satisfaction Rating Scale (NSRS)(Assessed at 10 and 11 years after implantation)
- Health related quality of life (EQ-5D-5L)(Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months)