A Prospective, Multicenter, Single Arm Adaptive-Design Study to Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial
研究概览
简要总结
Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery versus Post-Surgery data for:
- Range of Motion
- Quality of Life measurements using Knee Society Scale (KSS)
- Survivorship as defined by 'No Revision' of baseline implant
- Quality of Life measurements using the WOMAC Score
详细描述
The clinical study will involve a series of evaluations performed by your surgeon. These examinations are consistent with the normal surgeon care as part of Total Knee Replacement surgery. The study objective is to assess the safety, functionality, and survivorship of the Freedom Knee System through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery (baseline) versus Post-Surgery data for Range of Motion and Flexion, Quality of Life (KSS), and survivorship (defined by 'no revisions'). Additionally, the structural integrity will be evaluated based on the x-ray performed 36-months after knee replacement.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females 40-80 years of age
- •Patients requiring knee prosthesis, and have been evaluated as appropriate candidates for aTKA by their orthopedic surgeon
- •Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation
排除标准
- •Previous major knee replacement of the affected knee joint
- •Other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, nueropathic joints)
- •Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI > 35)
- •Patients who are found to be non-compliant by their physician
- •Patients with or having; malignancy - active malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus.
- •The patient has a neuromuscular or neurosensory deficit.
- •Female patients planning a pregnancy during the course of the study.
- •Patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- •Varus or valgus deformity > 20 degrees
结局指标
主要结局
Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial
时间窗: 3 years
The study is hoping to assess the safety of the implant by looking at the incident of revisions to the implant post surgery up to and including 3 years
次要结局
未报告次要终点