A Prospective, Multi-center, Single Arm Adaptive-design Study to Evaluate the Survivorship of the Maxx Orthopedics' PCK System in Revision Cases
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Survivorship
研究概览
简要总结
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.
详细描述
The clinical investigation is designed to be prospective to ensure that the population is representative of the type of population for which the Freedom Total Knee® System with the revision components is intended to treat. Subjects with a primary diagnosis of end-stage symptomatic revision knee who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a revision total knee arthroplasty, by the Investigator, will be invited to take part in this clinical investigation. Patients will be drawn from hospital clinics focusing on this type of treatment.
The treatment period of 36 months is considered sufficient to monitor the safety and clinical performance of the device. However, the patients will be contacted annually for 10 years or as long as the patient is willing to monitor their long-term progress.
An interim report will be issued when at least 120 patients will complete the 12-month follow-up.
No treatments will be withheld as part of this clinical investigation although any other treatments that need to be administered during the clinical investigation will be recorded.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 40 years of age or older and less than 80 years of age (>40 and <80 years).
- •Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
- •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.
- •Subjects who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
排除标准
- •Primary 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, neuropathic joints)
- •Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living.
- •Patients who are found to be non-compliant by their physician
- •Patients with or having; malignancy - active malignancy, active or suspected systemic 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
- •Bilateral TKR
结局指标
主要结局
Survivorship
时间窗: 36 months
"No Explants"
次要结局
- WOMAC(36 months)
- ROM(36 months)
- KSS(36 months)
- Revision rates of any component (including insert) for any reason except infection.(36 months)
- Revision rates of any component (including insert) for any reason.(36 months)