L'Alignement cinématique Dans Les prothèses de Totales de Genou : un Essai randomisé contrôlé à Double Insu Comparant la Robotique Aux Instruments Traditionnels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Radiographic alignment of the knee
研究概览
简要总结
Knee replacement surgery is a surgery designed to treat severe arthritis of the knee. However, as many as 20% of patients are not satisfied with the results of their surgery. To place the knee replacement in correct position, the kinematic alignment method, which tries to reproduce the patient normal anatomy, has shown promise in improving the satisfaction after knee replacement surgery. It is not known if using a robotic arm to assist in surgery is better than the traditional method when trying to recreate kinematic alignment.
The goal of this study is to learn if robotic assisted surgery is better than traditional method for knee replacement done using kinematic alignment. The main questions the study tries to answer are:
- Do the radiographs of kinematic knee replacement surgeries done with robotic assistance show better alignment than radiographs of kinematic knee replacements done with the traditional method?
- Does robotic assisted kinematic knee replacement give better function to patients than traditional knee replacement done with kinematic alignment?
- Does robotic assisted kinematic knee replacement decrease pain, improve knee movement and improve knee stability better than traditional knee replacement done with kinematic alignment?
- Are there more complications with robotic assisted kinematic knee replacement in comparison to traditional kinematic knee replacement?
- How long long does it take a surgeon to become good a performing a kinematic knee replacement using robotic assistance? Researchers will compare knee replacements done using a robotic to make the bone cuts, and compare it to the usual method using guides and manual instruments. All the knee replacements will be done using the kinematic alignment and with the same type of knee replacement prothesis.
Participants will:
- Have a knee replacement done with the kinematic alignment technique by an experienced surgeon, with or without robotic assistance during the surgery.
- Visit the clinic before surgery, six weeks after surgery, three months, six months, twelve months and twenty-four months after the surgery.
- Fill questionnaire, have their knee examined and have radiographs of their knee done at each visit.
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)
盲法说明
Statistician will be blinded to the intervention
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
- •Patient aged 18 or above
- •Patient being consented for a primary total knee arthroplasty (TKA)
- •The primary TKA is planned to be done with kinematic alignment
- •All pre-operative alignments are included
排除标准
- •Revision TKA (including revision of unicompartimental knee arthroplasty into total knee arthroplasty with primary components). TKA being done in the setting of previous femur or tibia fracture or osteotomy are however included.
- •No available adequate pre-operative imaging
- •Patient who does want to be randomized of the two groups
- •At the discretion of the surgeon, if the patient's pathology or particular anatomy precludes the use of kinematic alignment technique, robotic surgery, or traditional instrument TKA.
研究组 & 干预措施
Kinematic knee replacement with traditional instruments
Patients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides
干预措施: Kinematic aligned total knee replacement (Procedure)
Robotic-assisted kinematic knee replacement
Patients will undergo kinematic aligned knee replacement done using robotic assistance
干预措施: Kinematic aligned total knee replacement (Procedure)
结局指标
主要结局
Radiographic alignment of the knee
时间窗: Pre-operative alignement and 6 months post-operative alignement.
Long leg anteroposterior views of both legs and lateral knee radiographs will be used to measure knee alignment and position of the knee replacement hardware. The angles measured and analyzed will be: * The hip-knee-ankle (HKA) angle * Medial proximal tibia mechanical angle (MPTAm) * Lateral distal femur mechanical angle (LDTAm) * Distal femur flexion angle (DFFA) * Posterior tibial slope (PTS) Radiographic measurements will be made by a trained observer and a fellowship-train arthroplasty surgeon.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative
Patient questionnaire (42 questions) evaluating knee pain, symptoms, function, recreational activities and knee-related quality of life. The questionnaire is score over 100 points, with a higher score meaning better knee function.
Forgotten joint score
时间窗: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-op
A 12-questions form asking patients if they forget about their joint during activities of daily living.
Joint perception question
时间窗: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative
A single item question asking participants how they perceive their operated knee, from "like a native or natural joint" to "like a nonfunctional joint".
次要结局
- Pain visual analog scale(Pre-op, 6 weeks, 6, 12, 24 months)
- Subjective Assessment Numeric Evaluation Scale (SANE)(Pre-op, 6 weeks, 6, 12, 24 months)
- Knee range of motion(Pre, 6 weeks, 6 and 12 months post-op)
- Knee stability(Pre-op, 6 weeks, 6 and 12 months post-op)
研究者
Samuel Larrivée
Orthopaedic Surgeon
Université de Sherbrooke