Comparative Study on the Medium- and Long-term Benefits of Prosthesis Selection in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,500
- 主要终点
- Knee Function Score at 1 Year After Surgery
研究概览
简要总结
This retrospective real-world study aims to compare the medium- and long-term clinical outcomes, safety, and economic benefits of different knee prosthesis brands used in primary unilateral total knee arthroplasty (TKA) at our hospital. The study will include adult patients who underwent first-time unilateral TKA between January 1, 2022 and December 31, 2025. Outcomes such as postoperative knee function, complications, length of hospital stay, quality of life, and medical costs will be evaluated. The results are expected to provide evidence to support prosthesis selection and optimize healthcare resource allocation.
详细描述
This is a single-center, retrospective, open-label, non-randomized cohort study based on real-world clinical data from the Second Affiliated Hospital of Wenzhou Medical University.
The study population will include all adult patients who underwent first-time unilateral primary total knee arthroplasty (TKA) between January 1, 2022 and December 31, 2025. Patients who underwent revision arthroplasty, simultaneous bilateral arthroplasty, concomitant arthroplasty of other joints, arthroplasty for tumor or acute trauma, or who had severely incomplete data will be excluded.
Participants will be grouped according to the prosthesis brand and model documented in the operative record. Baseline variables will include age, sex, body mass index, preoperative diagnosis, ASA classification, comorbidities, and preoperative knee function score. Surgery-related variables will include prosthesis brand and model, fixation method, operative duration, intraoperative blood loss, surgeon seniority, use of a tourniquet, and drainage duration.
The primary outcome will be knee function score at 1 year after surgery, assessed using the HSS score or KSS score. Secondary outcomes will include postoperative complications, length of hospital stay, functional recovery, quality of life, and patient-reported outcomes at different postoperative time points. Economic outcomes will include direct medical costs, direct non-medical costs, indirect costs, and cost-effectiveness analysis. Safety outcomes will include all postoperative adverse events.
The objective of this study is to comprehensively compare the medium- and long-term clinical effectiveness, safety, and economic benefits of different prosthesis brands used in TKA, and to provide evidence to support clinical prosthesis selection and healthcare resource optimization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years.
- •Diagnosis of end-stage knee osteoarthritis, rheumatoid arthritis, or other conditions meeting the indication for TKA.
- •First-time unilateral knee arthroplasty.
- •Complete medical records, including perioperative records, prosthesis model records, detailed cost information, and regular postoperative follow-up records.
排除标准
- •Revision knee arthroplasty, simultaneous bilateral arthroplasty, or concomitant arthroplasty of other joints.
- •Arthroplasty performed for non-degenerative conditions such as tumour or acute trauma.
- •Perioperative death or loss to follow-up.
- •Severely incomplete clinical data that preclude valid analysis.
研究组 & 干预措施
Mainstream Prosthesis Cohort
Patients who underwent first-time unilateral primary total knee arthroplasty (TKA) using established mainstream prosthesis brands during the study period.
Emerging Prosthesis Cohort
Patients who underwent first-time unilateral primary total knee arthroplasty (TKA) using emerging prosthesis brands during the study period.
结局指标
主要结局
Knee Function Score at 1 Year After Surgery
时间窗: 1 year after surgery
The KSS ranges from 0 to 100, with higher scores indicating better knee function.
次要结局
- Postoperative Complications(Perioperative through 5 years after surgery)
- Length of Postoperative Hospital Stay(From surgery to hospital discharge, assessed up to 30 days)
- Postoperative Knee Function Score(1 month, 3 months, 6 months, 3 years, and 5 years after surgery)
- Quality of Life and Patient-Reported Outcomes(1 month, 3 months, 6 months, 3 years, and 5 years after surgery)
- Direct Medical Costs(From hospitalization through 5 years after surgery)
- Direct Non-Medical Costs(From hospitalization through 5 years after surgery)
- Indirect Costs(From hospitalization through 5 years after surgery)
- Incremental Cost-Effectiveness Ratio(At end of analysis)
- Postoperative Adverse Events(From surgery through 5 years after surgery)