A Post-Market Domestic (US) and International Data Collection to Assess Exactech Knee Systems
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,879
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
This is a multi-center, open-label, prospective and retrospective clinical outcomes study. Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive an Exactech Knee System total knee arthroplasty (TKA) prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
Subjects will, or will have already, undergo/undergone TKA as prescribed by the operating surgeon in a medical center with appropriate facilities and appropriately trained personnel. Treatment will be with the knee replacement components described in this protocol. The surgical procedure shall be conducted according to the appropriate Surgical Technique (Reference #: 712-35-41 and 712-35-35 as applicable) and product labeling for an Exactech Knee System and in accordance with the standard of care of the operating surgeon.
The medical devices and procedures used in this study are considered standard of care and are not considered investigational or experimental.
Information about the subject's preoperative conditions, demographics, previous surgical procedures, devices used, surgical procedure, postoperative outcomes, radiographic outcomes, and adverse events should be collected according to the Protocol Activity Schedule below:
Cohort 1. Prospective Subjects Enrolled in the study pre-surgery:
Cohort 2. Retrospective-to-Prospective Subjects - Subjects Enrolled in the study post-surgery.
Cohort 3. Retrospective Only Subjects - Data collection for the Retrospective Only Subjects will occur through a retrospective, observational, medical chart review.
Visit & Windows of data to be collected for all Cohorts:
- Preoperative Visit- Within ≤ 3 months prior to surgery
- Surgery/Discharge -Day of Surgery /Day of Discharge
- 6 Week Post-Op Visit - (Porous cohort only) -3 weeks - 7 weeks
- 6 Month Post-Op Visit - (Required for porous, optional for cemented) - 8 weeks - 26 weeks
- 1 through 10 Year Post-Operative Follow-Up Visits (As per the surgeon's standard of care) - ±6 months
Clinical Outcomes to be collected (only if available for Cohort 3):
- Functional Performance
- Range of Motion
- Patient Outcomes to be collected (only if available for Cohort 3):
- Knee injury and Osteoarthritis Outcome Score for Joint Replacement Jr. (KOOS Jr.)
- Knee Society Score (KSS) / Hospital for Special Surgery Score (HSS)
- Oxford Knee Score (OKS)
- Visual Analog Scale (VAS) for Pain and Patient Satisfaction
- Safety Outcomes:
a. Adverse Events
- Procedure-related adverse events,
- Device related adverse events,
- Readmissions, and Revisions b. Radiographic Outcomes (Assessment) (e.g., radiolucent lines, subsidence) c. Survivorship Rates - Kaplan Meier Analysis with a survivorship distribution function
详细描述
- Sample Size and Justification
Enrollment targets are based on, but not limited to, a sample size of 1879 primary subjects. Subjects will be enrolled based on a statistical estimation of the sample size needed to examine the primary outcome of survivorship (i.e., implant revision). The below table describes the distribution of enrollment. Additional subjects and component types may be enrolled beyond those described below.
- Truliant CR, n=308 Cemented Femoral, n=154 Porous Femoral, n=154 Tibial Insert CR, n=154 Tibial Insert CRC, n=154
- Truliant PS, n=610 Cemented Femoral, n=305 Porous Femoral, n=305 Tibial Insert PS, n=305 Tibial Insert PSC, n=305
- Logic CR, n=308 Cemented Femoral, n=154 Porous Femoral, n=154 Tibial Insert CR, n=154 Tibial Insert CRC, n=154
- Logic PS, n=610 Cemented Femoral, n=305 Porous Femoral, n=305 Tibial Insert PS, n=305 Tibial Insert PSC, n=305
- Constrained Condylar Components, n=43 CC Cemented Femoral Components, n=43 CC Tibial Inserts, n=43
Each product's subgroups share the same parameters and assumptions resulting in equal sample size. Sample sizes are estimated by component to ensure sufficient clinical data on each Total Knee Arthroplasty (TKA) component from each system. Because a patient must undergo a TKA with both a tibial insert and a femoral component, that individual patient will count toward the sample size for each component. All calculations consider an estimated 40% attrition rate.
The sample size calculations indicate the estimated width of the 95% confidence limits for the primary endpoint, namely implant survivorship at 10 years, based on data obtained from the literature. The calculation generated a proposed sample size sufficient to support a 10-year survivorship analysis. To ensure data consistency and quality across the planned study time points, the sample size estimation is applied to the prospectively enrolled subjects only.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- 未提供
排除标准
- •Patient was <18 years of age at time of surgery Patient does not meet indicated population for use criteria for this device. Patient is pregnant Patient is a prisoner Patient has a physical or mental condition that would invalidate the results Patient is contraindicated for the surgery (e.g., metal allergy)
结局指标
主要结局
Primary Objective
时间窗: 10 Years
The objective of this study is to assess the safety and performance of Exactech Knee System devices. Data will be collected to provide objective evidence of safety and performance of Exactech Knee Systems used in primary knee arthroplasty. Data may be analyzed to support future presentations and publications of an Exactech Knee System and may be used to provide clinical evidence of the post market outcomes of Exactech Knee Systems to regulatory authorities when required. The following data will be collected: Demographics (e.g., height, weight, age, and gender), Preoperative information (e.g., indication for surgery, comorbidities, pre-surgical assessments of knee function), Operative details (e.g., intra-operative findings, surgical approach, length of surgery), Product information (components used in the knee surgery), Adverse events (e.g., infection, device failure, revision), Implant survivorship, \& Patient Reported Outcomes (KOOS, KSS, HSS, OKS and/or VAS)
次要结局
- Secondary Objective(10 Years)