NCT02527161已完成不适用
A Prospective, Non-randomized, Longitudinal Study of the Clinical Outcomes of Participants That Receive the Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 主要终点
- Implant Location/Assessment of Alignment
研究概览
简要总结
This is a prospective, non-randomized, longitudinal study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.
Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. This sub-study involved the assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and post-operatively. An assessment of post-operative patient outcomes compared to pre-operative status was also analysed.
详细描述
Protocol Attached in documentation.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is a male or non-pregnant female between the ages of 50-
- •The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
- •The patient has a primary diagnosis of osteoarthritis (OA).
- •The patient has intact collateral ligaments.
- •The patient is able to undergo MRI scanning of the affected limb.
- •The patient has signed the study specific, HREC-approved, Informed Consent document.
- •The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
排除标准
- •The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
- •The patient has had a high tibial osteotomy or femoral osteotomy.
- •The patient is morbidly obese (BMI ≥ 40).
- •The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
- •The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
- •The patient has a fixed flexion deformity ≥ 15°.
- •The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- •The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- •The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- •The patient has a cognitive impairment, an intellectual disability or a mental illness.
- •The patient is pregnant.
- •The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
- •The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
结局指标
主要结局
Implant Location/Assessment of Alignment
时间窗: 3 months Post-Operatively
Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL(Pre-operative to 5 years post-operative)
- Knee Society Clinical Rating System (KSS) Range of Motion Scores(Pre-operative to 5 years Post-Operative)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain(Pre-operative to 5 years post-operative)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms(Pre-operative to 5 years post-operative)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R(Pre-operative to 5 years Post-Operative)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL(Pre-operative to 5 years post-operative)
- Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)(Pre-operative to 5 years Post-Operative)
- VAS Pain at Rest(Pre-Operative to 5 years Post-Operative)
- Knee Society Clinical Rating System (KSS) Pain Scores(Pre-operative to 5 years Post-Operative)
- Forgotten Joint Score (FJS)(1 to 5 years Post-Operative)
- VAS Pain Mobilised(Pre-Operative to 5 years post-operative)
- Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)(Pre-operative to 5 years Post-Operative)
- Knee Society Clinical Rating System (KSS) Functional Scores(Pre-operative to 5 years Post-Operative)
研究者
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