Comparison of post-operative pain, early rehabilitation and functional outcomes of robotic-arm assisted total knee arthroplasty (TKA) versus conventional TKA in bilateral simultaneous TKA a prospective double blinded randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale for Pain (VAS Pain) for assessment of post-operative pain, scored for each knee separately
研究概览
简要总结
Total Knee Arthroplasty (TKA) is the most successful procedure for the treatment of knee arthritis, providing consistent pain relief and return to activity after surgery. After several decades of surgical refinement and research, it is commonly accepted that one of the important factors influencing outcomes after TKA is the limb alignment and proper positioning of implants. Compared to conventional or manual jig-based TKR, Robot-arm assisted TKA has been proven to significantly improve accuracy of component positioning and to meet alignment targets reliably and reproducibly.
With robot-arm assisted TKR, the bone cuts are planned and controlled down to a millimeter. The saw blade excursion into bone and surrounding soft-tissues is highly controlled and restricted to a pre-determined area by haptic technology. These factors help in reducing soft-tissue insults of surgery. Since surgeons do not have to place jigs, the soft tissue dissection for exposure is also minimised.
There are multiple confounding factors in the assessment and comparison of robotic-arm versus manual TKR between patients like- grade of arthritis, severity of deformity, pain subjectivity, weight and BMI of patients etc. This is the basis behind our methodology of performing Robotic-arm assisted TKA (RATKA) and conventional TKA in the same patient undergoing bilateral TKA in the same sitting, without any added financial implications for the patient.
We hypothesize that robot-arm assisted TKR is associated with reduced pain, faster rehabilitation and better functional outcomes compared to manual or conventional TKR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with bilateral primary osteoarthritis of the knee
- •Both knees with symmetrical deformities (varus or valgus)
- •Radiologically same stage of OA Knee as per the Kellgren-Lawrence grading system.
- •Patients who consent to undergo simultaneous bilateral TKR, And to receive manual/conventional jig-based TKR on one side and Robot-arm assisted TKR on the other side (as decided by computer generated randomization).
排除标准
- •Inflammatory arthropathy Asymmetrical knee deformities Differential stage of arthritis of the knee in the same patient previous surgery on the knee.
结局指标
主要结局
Visual Analogue Scale for Pain (VAS Pain) for assessment of post-operative pain, scored for each knee separately
时间窗: Visual Analogue Scale for Pain (VAS Pain) for assessment of post-operative pain | 6,12,18,24,36,48 hours after surgery | 1,3,6,12 months after surgery
次要结局
- Additional Analgesic requirements calculated by(1. Number of doses of intravenous Fentanyl or SC Morphine, Intravenous tramadol)
- Knee Range of Motion (ROM) Active ROM of each knee measured in degrees(24,48 hours)
- Use of aids to walk (eg. 4-frame walker, crutches, single-cane, unaided)(24, 48 hours after surgery)
- Forgotten Joint Score (FJS)(1,3,6,12 months)
- Knee Range of Motion (ROM) Passive ROM of each knee measured in degrees(24, 48 hours after surgery)
- EQ-5D score(1,3,6,12 months)
- Knee Society Score(1,3,6,12 months)
- Distance walked in 3 minutes (in meters)(24, 48 hours after surgery)
- Oxford Knee Score (OKS)(1,3,6,12 months)
- WOMAC Score(1,3,6,12 months)
- Limb alignment: CT based measurement of Hip-Knee-Ankle angle measurement in degrees(Immediately Post-operative)