Is Clinical Outcome of Robotic-Assisted TKA Better Than Conventional Manual TKA?Prospective, Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 674
- 主要终点
- Knee society Knee score
研究概览
简要总结
Robotic-assisted total knee arthroplasty (TKA) was introduced to attempt to enhance the precision of bone preparation, component alignment and ultimately improve clinical results and survivorship of TKA. Although several published data suggest that bone preparation, and knee component alignment were improved by using robotic assistance, there is no high-quality evidence from randomized trials at long-term of which investigators are aware evaluating whether the improved bone preparation and knee component alignment improved clinical function or longevity of the TKA.
详细描述
Robotic-assisted TKA was introduced in an attempt to enhance component alignment and to improve long-term clinical results and implant durability, particularly in younger patients. Several comparative studies of conventional and robotic-assisted TKAs demonstrated that improved alignment of the components was obtained after the robotic-assisted TKAs than conventional TKAs.
To date, however, no comprehensive synthesis of long-term randomized data has been conducted specifically for robotic-assisted TKA, particularly in younger patients. It is crucial to determine whether improved alignment of the TKA components obtained by using robotic-assistance, would improve better long-term and functional results and survivorship of TKAs.
The aims of the current study were to examine the two groups of patients after long-term follow-up to determine whether the clinical results, radiographic and CT scan results, and the survivorship of TKA would be better after robotic-assisted TKA than after conventional TKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •end stage knee arthritis
排除标准
- •mild knee deformity
- •inflammatory arthritis
- •foot and ankle disorder
- •hip disease
- •history of a stroke
- •older than 65 years of age
研究组 & 干预措施
Robot
TKA is done with robotic-assisted manner. Final implantation of implants is done by surgeons, same as the conventional way. Robotic-assisted TKA for this arm.
干预措施: Robotic-assisted TKA (Procedure)
Conventional
TKA is done with conventional instruments. Conventional TKA for this arm.
干预措施: Conventional TKA (Procedure)
结局指标
主要结局
Knee society Knee score
时间窗: 20 years after the surgery
a proven score for the measurement of knee function, the score ranges from 0 to 100, 100 being the best possible score, indicating normal knee function
次要结局
- WOMAC score(20 years after the surgery)
研究者
Young Hoo Kim
Professor
Ewha Womans University