NCT02655809已完成不适用
Physica KR: In Vivo Kinematic Analysis of a Novel Total Knee Replacement Implant
Limacorporate S.p.a2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Assessment of the roll-back mechanism by measuring the contact point between tibia and femur components in millimeters
研究概览
简要总结
The aim of this study is to assess the in vivo kinematics and range of motion of a single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining total knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of the normal healthy knee.
Patients would be evaluated by fluoroscopic examination during weight bearing activities (lounging, kneeling and stairs climbing).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patientsoperated in The Royal Bournemouth Hospital NHS Foundation Trust and who has received a Physica KR implant
- •Patients achieving a ROM ≥ 100° at 6 week follow-up in the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
- •Patients affected by primary or secondary OA before surgery;
- •Patients with an appropriate intial fixation and stability of the knee prosthesis;
- •Patients with undamaged and functional collateral and posterior cruciate ligaments (no ligamentous imbalance or pain);
- •Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination;
- •Patients who have signed the Ethics Committee approved study-specific Informed Consent Form.
排除标准
- •Patients with a ROM < 100° at 6-week follow-up in Physica KR clinical trial (K-06- Study protocol 30/10/2013 v 1.0);
- •Patients affected by rheumatoid arthritis;
- •Patients with malalignment or axial malrotation of the knee prosthesis;
- •Patients who had or have planned a surgery on their uninvolved knee within a year;
- •Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance;
- •Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation;
- •Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device;
- •Any psychiatric illness that would prevent comprehension of the details and nature of the study;
- •Participation in any experimental drug/device study within the 6 months prior to the preoperative visit, excluding the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
- •Female patients who are pregnant, nursing, or planning a pregnancy.
结局指标
主要结局
Assessment of the roll-back mechanism by measuring the contact point between tibia and femur components in millimeters
时间窗: 6 months after surgery
Using a software to replicate the movement using CAD models. The movement is studied and the distance made by the femur on the tibia is calculated giving the information of the roll back.
次要结局
未报告次要终点
研究者
研究点 (2)
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