Prospective, Multicentre, Single-arm, Open, Confirmatory Trial to Assess Efficacy and Safety of a Navigation System Providing Personalized Soft Tissue Balance Data in Medially-stabilized Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Oxford Knee Score (OKS)
研究概览
简要总结
The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).
详细描述
This is a prospective, multicentre, single-arm, open, confirmatory clinical investigation to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).
Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.
The study is conducted according to the following schedule:
- V1 : Inclusion during a preoperative visit
- V2: Surgery
- V3: Follow-up visit at 2 month post-surgery
- V4: Follow-up visit at 6 months post-surgery
- V5: Follow-up visit at 12 months post-surgery
The following data will be collected:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males and females aged over 18 years at time of surgery.
- •Patients who are scheduled to receive Medacta GMK® Sphere system for primary TKA (class III, CE-marked).
- •Patients with functional contralateral knee (i.e. without the need to use walking aids).
- •Patients willing and able to provide written informed consent for participation.
- •Patients willing to comply with the pre and post-operative evaluation schedule.
排除标准
- •Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study:
- •Patients presenting with progressive local or systemic infection
- •Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable.
- •Severe instability secondary to advanced destruction of condralar structures or loss of integrity of the medial or lateral ligament
- •Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
- •Patients affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity.
- •Patients unable to understand and take action.
- •Patients with known allergy to the materials used.
- •Patients in which Medacta GMK® Sphere system is used in emergency interventions.
结局指标
主要结局
Oxford Knee Score (OKS)
时间窗: 6 months
Oxford Knee Score (OKS) \[Range: 0-48; higher values indicate better outcomes\]
次要结局
- Oxford Knee Score (OKS)(12 months)
- Forgotten Joint Score (FJS)(6 months and 12 months)
- Objective Knee Society Score (KSS)(6 months and 12 months)
- Radiological Outcomes(2 months and 12 months)
- Surgical Outcome - Surgical Time(Intraoperative)
- Surgical Outcome - Necessity of Soft Tissue Release(Intraoperative)
- Surgical Outcome -Time to Discharge(2 months)
- Safety Outcomes(Intraoperative, 2 months, 6 months and 12 months)