A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 111
- 试验地点
- 16
- 主要终点
- Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).
研究概览
简要总结
The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) functional results of the Triathlon Cruciate Retaining (CR) Total Knee.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is a male or non-pregnant female 21-75 years of age at the time of enrollment.
- •The subject requires a primary cemented unicompartmental knee replacement.
- •The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA).
- •The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present.
- •The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion.
- •The subject's preoperative mechanical alignment is less than 15 degrees of varus and 15 degrees of valgus.
- •The subject has signed the Institutional Review Board (IRB) approved study specific Informed Patient Consent Form.
- •The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •The subject has inflammatory arthritis or avascular necrosis(AVN).
- •The subject is obese, BMI >
- •The subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint.
- •The subject has a history of anterior cruciate ligament (ACL) reconstruction.
- •The subject has had a high distal femoral, or proximal tibial osteotomy.
- •The subject has a mental, neuromuscular or neurosensory disorder, which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in post-operative care and/or limit the ability to assess the performance of the device.
- •The subject has a systemic or metabolic disorder leading to progressive bone deterioration that the surgeon feels would affect the overall outcome of the study.
- •The subject is immunologically suppressed, or is receiving chronic steroids (>30 days duration).
- •The subject has a known sensitivity to device materials.
- •The subject's bone stock is compromised by disease and/or infection which cannot provide adequate support and/or fixation to the prosthesis.
- •The subject's bone stock is compromised by a prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- •The subject has an active or suspected latent infection in or about the knee joint.
- •The subject is a prisoner.
结局指标
主要结局
Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).
时间窗: 10 years
The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS). This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome.
次要结局
- 10-years Kaplan Meier Survival Analysis(10-years)