NCT05459948招募中不适用
Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 281
- 试验地点
- 4
- 主要终点
- Primary objective will be evaluated with the Forgotten Joint score (FJS).
研究概览
简要总结
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
详细描述
The aim of the current study is to collect clinical and radiological data to monitor the performances of the "GMK® SpheriKA" Knee Prosthesis implanted via the kinematic alignment technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to sign the informed consent.
- •Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.
- •Patients 18 - 80 years of age at the time of surgery.
- •Patients requiring a primary total knee replacement (on label use).
- •Patients with intact collateral ligaments.
排除标准
- •Patients with inflammatory arthritis.
- •Morbidly obese patients, with a body mass index (BMI) >
- •Patients with a history of total or unicompartmental reconstruction of the affected joint.
- •Patients that have had a high tibial osteotomy or femoral osteotomy.
- •Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- •Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
- •Patients that are immunologically compromised or receiving chronic steroids (> 30 days).
- •Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis.
- •Patients with an active or suspected latent infection in or surrounding the knee joint.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Primary objective will be evaluated with the Forgotten Joint score (FJS).
时间窗: 6 weeks, from 1 to 10 years annually
study the efficacy of the treatment to make the patient forget the presence of the artificial joint in everyday life. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
次要结局
- Limb alignment(on preoperative and 6-week x-rays)
- Satisfaction and Expectations questionaires(6 weeks, from 1 to 10 years annually)
- Lateral uncoverage of the anterior femoral resection(During Surgical Operation)
- Radiological outcomes(pre-op, 6weeks, 1, 2,5,10 years)
- patient-reported outcomes 1(6 weeks, from 1 to 10 years annually)
- Adverse events(during surgical operation, 6weeks, 1,2,5,10 years)
研究者
研究点 (4)
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