Randomised control trial: Evaluating the clinical outcomes of mechanical alignment using gap balancing and kinematic alignment using measured resection in TKR
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Clinical outcomes will be assessed using various validated measures, including the Oxford Knee Score, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Visual Analog Scale (VAS) for pain and functional improvement.
研究概览
简要总结
This is a Randomised Control Trial to evaluate the clinical outcomes of mechanical alignment using gap balancing and kinematic alignment using measured resection in total knee replacement (TKR) surgery for 18 months in 140 patients with Osteoarthritis of knee. The study will be conducted at AFMC India. The primary outcome will be assessed using various validated measures, including the Oxford Knee Score, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Visual Analog Scale (VAS) for pain and functional improvement. All patients will undergo regular follow-up evaluations at predetermined intervals (6 weeks, 3 months, 6 months, and 1 year).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with advanced knee osteoarthritis deemed suitable candidates for total knee replacement (TKR).
- •Age 18 years or older.
- •Willingness and ability to provide informed consent for participation in the study.
- •Patients scheduled to undergo primary TKR.
- •Ability to comply with the follow-up schedule and study procedures.
- •Adequate cognitive and physical capacity to complete study assessments and follow instructions.
排除标准
- •History of significant knee trauma resulting in deformity or instability.
- •Diagnosis of inflammatory arthritis affecting the knee joint (e.g., rheumatoid arthritis, psoriatic arthritis).
- •Previous knee surgeries including partial or total knee replacements, osteotomies, or ligament reconstructions.
- •Presence of significant comorbidities that may affect surgical outcomes or compliance with study procedures.
- •Contraindications to TKR surgery as determined by the treating orthopedic surgeon.
- •Inability or unwillingness to provide informed consent for study participation.
- •Pregnant or breastfeeding women.
- •Any condition or circumstance that, in the opinion of the investigator, would compromise the safety or scientific integrity of the study or the well-being of the participant.
结局指标
主要结局
Clinical outcomes will be assessed using various validated measures, including the Oxford Knee Score, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Visual Analog Scale (VAS) for pain and functional improvement.
时间窗: The patients will be evaluated by followup on 6 weeks , 3 months , 6 months and 1 yearafter surgery
次要结局
- Radiographic measurement of alignment angles, implant positioning, & assessment of component fit.(The patients will be evaluated by followup on 6 weeks , 3 months , 6 months & 1 year after surgery)
研究者
Nidhin Jose
Armed Forces Medical College