Anatomo-functional Correlation Between Intra-operative Passive Kinematics Recorded by Navigation and Post-operative Kinematics Analyzed by Dynamic Weight Bearing RSA of the Operated Knee.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation of the femoral rotations and translations during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking.
研究概览
简要总结
Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per year. Statistics indicate that for patients over 60 year old approximately one out of 20 will require corrective reoperations within 10 years after surgery. However, for patients younger than 60 years, approximately one out of 10 will require revision total knee arthroplasty within 10 years of surgery. As the number of younger patients is increasing, there has been a shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and implant longevity being the important issues for quality of patient care. Furthermore, it has been reported that up to 25% of patients are not satisfied with the functional results of their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However these are often static, because of even most advanced x-ray film exchanger limit the number of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction.
The purpose of this study is to investigate the effect of a new implant design on the post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A prospective randomized study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
详细描述
The main goal of this study is to investigate the effect of a new implant design on the postoperative active knee kinematics on mid-flexion instability of the joint. Data will be collected during the surgery with a Computer Assisted Surgery system and in the post operative follow up phase using the dynamic RSA focusing. A prospective study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
Kinematic tests will be performed to analyze femoral rotation patterns and translation patterns of the medial and femoral condyle respect to the tibial plateau during different daily life motor tasks.
Despite reportedly good implant survival rates, not all patients are fully satisfied after total knee arthroplasty (TKA). One of the most debated topics in TKA is the effectiveness of the prosthesis to reproduce physiological kinematics at the replaced knee, usually expressed in terms of patterns of joint rotation in the three anatomical planes, of the functional axis, and of the tibio-femoral contact points on the medial and lateral condyles, that is, femoral roll-back.
Implant design can influence final kinematic results. The mid-flexion instability may be the cause of joint instability, paradoxical femoral rollback, surgical variation.
Recently an improved implant design of fixed bearing PS DePuy implant has been anticipated to early users. This implant has been claimed to reduce midflexion instability and improve joint kinematics, because of a particular multiradius shape of the condylar surface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe radiographic osteoarthritis (Kellgren-Lawrence grade >3)
- •Patients scheduled for a primary TKA
- •Willing to take part in study and providing HIPAA authorization
排除标准
- •Previous corrective osteotomy on the affected lower limb
- •Post-traumatic arthritis
- •Severe preoperative valgus deformity (Hip Knee Ankle angle>10°)
- •BMI>40 kg/m2
- •Rheumatoid arthritis
- •Chronic inflammatory joint diseases
- •Patients with a pre-pathological abnormal gait (amputated, neuromuscular disorders, poliomyelitis, developmental dysplasia of the hip)
- •Severe ankle osteoarthritis (Kellgren-Lawrence>3)
- •Severe hip osteoarthritis (Kellgren-Lawrence>3)
- •Previous total hip or ankle replacement
- •Unwilling to take part in study and providing HIPAA authorization
结局指标
主要结局
Evaluation of the femoral rotations and translations during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking.
时间窗: 9 months
The joint kinematic was acquired using the dynamic RSA technique. The rotations (angular degree) and translations (millimeter) were evaluated using the Euler decomposition and the Low-point algorithm.
次要结局
- Correlation of clinical reported results (KSS, Oxford, SF36, WOMAC) and patients' subjective satisfaction using a visual analogue scale (VAS) with kinematics differences and ground reaction forces.(9 months)
- Quantification the ground reaction forces during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking.(9 months)
研究者
Stefano Zaffagnini
Full professor
Istituto Ortopedico Rizzoli