To compare clinical and radiological outcomes of conventional and robotic total knee replacement in patients with osteoarthritis of bilateral knee joint Academic trail
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Dr Raghunath
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- • To evaluate and compare functional outcomes by using standardised scoring systems- WOMAC ,OKS , VAS at defined postoperative intervals .
概览
简要总结
Comparing clinical and radiological outcomes of conventional and robotic total knee replacement (TKR) in patients with bilateral knee osteoarthritis is a pertinent area of research given the increasing adoption of robotic assistance. This type of study typically aims to determine if the perceived precision and potential benefits of robotic-assisted surgery translate into superior patient outcomes compared to traditional manual techniques.
A well-designed study would involve a cohort of patients suffering from end-stage osteoarthritis affecting both knees. These patients would ideally undergo TKR using both conventional and robotic techniques, either with one knee receiving conventional and the other robotic (a within-patient comparison, carefully considering potential confounding factors), or by randomizing patients to receive either conventional or robotic surgery for both knees.
The primary clinical outcomes would include patient-reported outcome measures (PROMs) such as the Knee Society Score (KSS), Oxford Knee Score (OKS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). These scores capture pain levels, functional limitations, and overall patient satisfaction, providing a holistic view of the recovery process and quality of life post-surgery. Range of motion and gait analysis would also be critical clinical assessments.
Radiological outcomes would focus on implant positioning and alignment, which are hypothesized to be more precise with robotic assistance. This would involve post-operative X-rays and potentially CT scans to assess parameters like component angles (femoral and tibial), joint line restoration, and mechanical axis alignment. The incidence of malalignment or outliers beyond acceptable ranges would be a key comparative metric.
Secondary outcomes could include surgical time, blood loss, length of hospital stay, and complication rates (e.g., infection, deep vein thrombosis, revision surgery). The study would need to ensure adequate follow-up periods (e.g., 1, 2, and 5 years) to evaluate long-term implant survival and functional stability. While robotic assistance often promises enhanced precision, the core question is whether this translates into clinically meaningful benefits for patients, such as reduced pain, improved function, and greater implant longevity, compared to the well-established conventional method. The findings would help inform surgical decision-making and potentially guide future advancements in TKR techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •a) Patients diagnosed with bilateral knee osteoarthritis with varus deformity .
- •b) patients aged between 50 and 80 years and also medically fit for bilateral TKR .
- •c) patient with ROM difference between bilateral knee not more than 10 degree and varus deformity difference less than 5 degree.
- •d) Patients willing to undergo one knee conventional and other knee robotic TKR after understanding all the possible complications and gives audiovisual consent for the procedure.
排除标准
- •a) Patients with inflammatory arthritis (e.g., rheumatoid arthritis).
- •b) Patients with a history of knee infections or previous knee surgeries.
- •c) patient with neuromuscular disorders affecting lower limb function .
- •d) Patients with fixed deformities of the knee joint e) Patients with any contraindications for surgery like severe cardiac ,renal ,pulmonary and any other severe systemic illness.
结局指标
主要结局
• To evaluate and compare functional outcomes by using standardised scoring systems- WOMAC ,OKS , VAS at defined postoperative intervals .
时间窗: 6 months
• To assess radiological outcomes such as implant positioning and alignment between robotic and conventional TKR using HKA angle, femoral coronal component angle (FFC),tibial coronal component angle (FTC),posterior tibial slope angle (PSA).
时间窗: 6 months
次要结局
- • To compare operative parameters such as duration of surgery , intra operative blood loss and need for soft tissue releases between robotic and conventional TKR(on the day of surgery)
研究者
Raghunath S
AIIMS Mangalagiri