Comparison of Patients-reported Outcome After Total Knee Arthroplasty With Use of Bi-cruciate Stabilized and Personalized Implant Design - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Values of components rotation
研究概览
简要总结
This study compares and evaluates differences in patient-reported outcome, survivorship and radiological analysis between patients undergoing total knee arthroplasty with use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith&Nephew Journey II Bi-Cruciate Stabilized (BCS) system
详细描述
The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith&Nephew Journey II Bi-Cruciate Stabilized (BCS) system.
To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.
Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales.
1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement
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
Participant will not be informed which type of prosthesis was used in their particular case.
Outcomes Assessor, who will be not present during surgery, will not be informed which type of prosthesis was used in particular patient.
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
- •Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
- •Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
- •Aged 18 or over
- •Patient willing to provide full informed consent to the trial
排除标准
- •Listed for a single-stage bilateral TKR procedure
- •Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
- •Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
- •Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
- •Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
- •Inflammatory arthritis
- •Previous septic arthritis in the affected knee joint
- •Previous surgery to the collateral ligaments of the affected knee
- •Patients on warfarin or novel oral anticoagulants (NOACs)
- •Will not be resident in the catchment area for at least 6 months post-surgery
- •Undertaking the surgery as a private patient
- •Patients who, in the opinion of the clinical staff, do not have capacity to consent
- •Patients who are pregnant
- •Unable to understand written and spoken Polish
研究组 & 干预措施
PERSONA
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system
干预措施: Total Knee Replacement (Device)
Journey II
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith&Nephew Journey II system
干预措施: Total Knee Replacement (Device)
结局指标
主要结局
Values of components rotation
时间窗: 1-day postoperatively
Values of external or internal rotation of components measured in computed tomography postoperatively. Values in degrees in regards to anatomic bone landmarks
Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)
时间窗: baseline (preoperatively) and 1 year postoperatively
To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)
时间窗: baseline (preoperatively) and 1 year postoperatively
To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 96, with higher scores corresponding to worse outcomes.
次要结局
未报告次要终点
研究者
Artur Stolarczyk
Head of the Department of Orthopedics and Rehabilitation
Medical University of Warsaw