Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Device Survivorship
研究概览
简要总结
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.
详细描述
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.
To maintain equal site distribution per device, patient recruitment will include up to a total of twenty (20) registry sites and thirty (30) primary TKA candidates per site / surgeon for a total of 600 registry patients. A total of no more than 200 patients across all sites will be recruited per level of constraint (e.g.: 200 CR, 200:PS, 200:UC) for this registry with a 10-month accrual target from study initiation per site (~3 patients consented / month).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for this registry must meet ALL of the following criteria:
- •Patient is > 18 years of age
- •Patient has failed attempts at non-operative conservative therapy
- •Patient has participated in the informed consent process and signed an IRB approved informed consent
- •Patient is scheduled to undergo unilateral or bilateral primary TKA of the knee
排除标准
- •Candidates will be excluded from the evaluation if ANY of the following apply:
- •Patients with previous TKA, UKA, HTO or knee fusion of the indicated knee
- •Patients that have undergone previous surgery of indicated knee for tumor, trauma or fracture
- •Evidence of active or suspected (systemic or local) infection at time of surgery
- •Other significant disabling problems from the musculoskeletal system than in the knee (i.e.: muscular dystrophy, polio, neuropathic joints)
- •Patients with or having; malignancy - active malignancy, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia and systemic lupus erythematosus
- •Patients with neuromuscular or neurosensory deficit
- •Women who are pregnant
- •Prisoner or transient
- •Recent history of known narcotic abuse
- •Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires
结局指标
主要结局
Device Survivorship
时间窗: 2 years
Revision / re-operation post-operatively due to device / device composite failure. An anticipated benefit of the device is that it is more conforming at higher degrees of flexion, which could potentially result in reduced polyethylene wear and improved survivorship over the longer-term. To assess this aspect of the device in addition to safety over the short-, intermediate- and long-term, survivorship analyses will be conducted at the targeted follow-up landmark timepoints. There will be 3 survivorship endpoints: * Revision of any component (including insert) for any reason * Revision of any component (including insert) for any reason except infection
次要结局
- Original Knee Society Scale (KSS)(3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months)
- Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)(3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months)
- Patient Reported Outcomes Measurement Information System (PROMIS Global-10)(3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months)
- Visual Analog Scale (VAS)(3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months)
- Forgotten Joint Score (FJS-12)(3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months)