A Retrospective/Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Survivorship
研究概览
简要总结
This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).
Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years.
详细描述
The purpose of this study is to evaluate the safety and performance of the Triathlon Hinge Knee System for both primary and revision cases in accordance with the Indications for Use.
The main objective of this study is to determine (1) mid- (5 year) and long-term (10 year) survivorship, and (2) drivers of failure for the Triathlon Hinge Knee (THK) hinge. Data from this study will be used to develop a predictive model to identify the most important factors in achieving fixation, including the role of augments, cones, thresholds for cement mantle thickness, and number of zones of fixation required for survivorship.
Survivorship is defined as the absence of aseptic revision to the implanted device.
The Triathlon Hinge Knee System consists of Triathlon Hinge femoral components, the Triathlon Revision baseplate, Triathlon Revision Tibial Augments, Triathlon Hinge Femoral Distal Augments, Triathlon Hinge Insert, Triathlon Revision Insert X3, and Triathlon Hinge Bumpers, Axle, Bushings, Tibial Sleeve, and Bearing component.
It is designed to be a single platform for revision, difficult primary, and limb salvage surgeries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject undergoes a primary or revision procedure implanting at least the Revision Baseplate portion of the Triathlon Hinge Knee System in accordance with the Indications for Use.
- •The subject has signed an Institutional Review Board (IRB)/Ethical Committee (EC)-approved, study-specific Informed Consent Form (ICF).
- •The subject is a male or non-pregnant female at the time of enrollment.
- •The subject agrees to comply with the protocol-mandated clinical evaluations.
排除标准
- •Any active or suspected latent infection in or about the knee joint; overt infection;
- •Distant foci of infection which may cause hematogenous spread to the implant site; rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram;
- •skeletally immature patients;
- •Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- •Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- •Known or suspected sensitivity and/or allergy to any material in the device.
- •Conditions presenting an increased risk of failure include:
- •uncooperative patient or patient with neurologic disorder, incapable of following instructions;
- •osteoporosis;
- •metabolic disorders which may impair bone formation or cause bone loss;
- •osteomalacia; and,
- •previous arthrodesis.
- •A higher incidence of implant failure has also occurred in paraplegics, cerebral palsy and patients with Parkinson's disease.
- •Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •The subject is a prisoner
研究组 & 干预措施
Total Stabilized (TS) Revision
Triathlon Total Stabilized (TS) Femoral Component+ Revision Baseplate
Revision (Maximum of 80 subjects)
Triathlon Total Stabilized (TS) Femoral Component + Revision Baseplate
干预措施: Triathlon Hinge Knee (THK) System (Device)
Modular Rotating Hinge (MRH) Revision
Modular Rotating Hinge (MRH) Femoral Component + Revision Baseplate
Primary
Triathlon Hinge Femoral Component + Revision Baseplate
干预措施: Triathlon Hinge Knee (THK) System (Device)
Revision
Triathlon Hinge Femoral Component+ Revision Baseplate
干预措施: Triathlon Hinge Knee (THK) System (Device)
Global Modular Replacement System (GMRS) Primary or Revision
Global Modular Replacement System (GMRS) Femoral Component + Revision Baseplate
结局指标
主要结局
Survivorship
时间窗: 1, 2, 6 and 10 years
To evaluate the survivorship of the Hinge Knee System at postoperatively. Survival is defined as the absence of aseptic revision to the implanted device.
次要结局
未报告次要终点