| 标题： | 机器人辅助髋膝关节置换手术临床指南 |
| title： | Protocol for clinical guideline of robot-assisted hip and knee arthroplasties |
| 版本： | 原创版 |
| version： | Original |
| 分类： | 标准指南 |
| classification： | Standard guideline |
| 领域： | 诊疗 |
| field： | Diagnosis and Treatment |
| 国家和地区： | 中国 |
| Country and region： | China |
| 指南使用者： | 骨科医师、关节外科医师、矫形外科医师等。 |
| Guide users： | Joint Surgeons, Orthopedic Surgeons |
| 证据分级方法： | 对纳入的系统评价/Meta分析使用系统评价方法学质量评价工具AMSTAR（A Measure Tool to Assess Systematic Reviews）；指南选用中国临床实践评价标准（Agree-China）；随机对照研究（Randomised Controlled Trials）采用Cochrane图书馆推荐的RCT偏倚风险评估工具（Risk of Bias，ROB），观察性研究使用纽卡斯尔-渥太华量表(Newcastle-Ottawa Scale,NOS)进行评价。评价由2人独立完成，存在分歧时由第3位研究员参与讨论并达成共识。 采用GRADE分级（grading of recommendations assessment，development and evaluation，GRADE）对每个临床问题纳入的研究进行证据质量、推荐意见及推荐强度分级。对于定性研究或不适合GRADE分级系统评估的证据，采用良好实践申明（good practice statement，GPS）进行评价。 |
| Evidence grading method： | The systematic evaluation/meta-analysis included in the study will use the AMSTAR (A Measure Tool to Assess Systematic Reviews) tool for methodological quality assessment. The guidelines will use the Chinese Clinical Practice Evaluation Standards (AGREE-China). Randomized controlled trials (RCTs) will use the Risk of Bias (ROB) evaluation tool recommended by the Cochrane Library, and observational studies will be evaluated using the Newcastle-Ottawa Scale (NOS). The evaluation will be completed independently by two researchers, and in case of disagreement, a third researcher will participate in the discussion to reach a consensus. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system will be used to grade the quality of evidence, recommendations, and recommendation strength for each clinical question included in the study. For qualitative research or evidence unsuitable for the GRADE system evaluation, a Good Practice Statement (GPS) will be used for evaluation. |
| 制定单位： | 国家卫生健康委能力建设和继续教育中心；中华医学会骨科学分会关节外科学组 |
| Formulating unit： | National Health Commission Capacity Building And Continuing Education Center; The Joint Surgery Branch of the Chinese Orthopaedic Association |
| 注册时间： | 2024-03-27 |
| Registration time： | |
| 注册编号： | PREPARE-2024CN470 |
| Registration number： | |
| 指南制订的目的： | 人工关节置换术（total joint arthroplasty, TJA）被认为是20世纪以来最成功的矫形外科手术之一，也是公认治疗终末期髋、膝骨关节疾病的最有效手段之一。在传统手术方式下，关节置换假体的植入很大程度上依靠术者的经验，存在很大盲目性和不确定性，可能出现假体位置角度安放不良、力线偏离、屈伸内外侧间隙不平衡等情况，是术后假体脱位、双下肢不等长、髌骨轨迹不良、垫片磨损和术后不稳定等并发症发生的主要原因，因此，仍有相当一部分患者术后效果不佳。 自Robodoc机器人系统问世以来，随着智能化、精准化和个性化的理念认识不断深入，手术机器人在关节外科领域得到了蓬勃发展。关节置换手术机器人可以实现精准、个性化的手术规划，并在术中辅助术者完成安装截骨工具、切削截骨、磨锉和安装假体等操作，提高了关节置换手术的精确性和安全性，达到减少围手术期并发症、加速康复、提高远期疗效等目标。但也有研究表明，由于理论知识和操作规范程度不足，部分机器人辅助关节置换术后并发症发生率增高，临床疗效不佳。 目前在我国对于机器人辅助（robot-assisted, RA）髋膝关节置换手术的临床实践缺乏指南指导。因此，有必要根据现有的文献证据制订临床实践指南，规范或指引临床医生实施机器人辅助髋膝关节置换手术。为解决上述问题，将根据世界卫生组织（World Health Orgnization，WHO）指南制订手册、运用证据推荐分级（the grading of recommendations assessment， development andevaluation，GRADE）等方法，制订《机器人辅助髋膝关节置换手术临床指南》。 |
| Purpose of the guideline： | Total joint arthroplasty (TJA) is considered one of the most successful orthopedic surgeries since the 20th century, and is also recognized as one of the most effective methods for treating end-stage hip and knee joint diseases. Under traditional surgical methods, the implantation of joint prostheses largely relies on the surgeon's experience, which leads to significant blindness and uncertainty. There may be poor placement of prosthetic positions, deviation of force lines, and imbalance of internal and external flexion and extension gaps, which are the main causes of postoperative complications such as dislocation of prostheses, unequal length of lower limbs, poor patellar trajectory, pad wear, and postoperative instability. Therefore, a considerable number of patients still have poor postoperative outcomes. Since the emergence of the Robodoc robot system, with the deepening understanding of the concepts of intelligence, precision, and personalization, surgical robots have flourished in the field of joint surgery. TJA robots can achieve precise and personalized surgical planning, and assist surgeons in installing osteotomy tools, cutting osteotomy, grinding files, and installing prostheses during surgery, improving the accuracy and safety of joint replacement surgery, achieving the goals of reducing perioperative complications, accelerating recovery, and improving long-term efficacy. However, some studies have shown that due to insufficient theoretical knowledge and operational standards, the incidence of complications after some robot assisted joint arthroplasties is increased, and the clinical efficacy is poor. At present, there is a lack of guidance on the clinical practice of robot assisted (RA) hip and knee arthroplasty surgery in China. Therefore, it is necessary to develop clinical practice guidelines based on existing literature evidence to standardize or guide clinical doctors in implementing robot assisted hip and knee replacement surgery. To address the aforementioned issues, a manual will be developed based on the World Health Organization (WHO) guidelines, and a clinical guideline for robot assisted hip and knee arthroplasty surgery will be developed using methods such as the grading of recommendations assessment, development and evaluation (GRADE). |
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