Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Five-Year Survivorship
研究概览
简要总结
This study will be conducted to assess the survivorship of a particular prosthesis used in unicompartmental knee arthroplasties. Patients undergoing this procedure have been diagnosed with isolated medial or lateral compartmental arthritis and have failed conservative treatment. The patients received a unicompartmental knee replacement using the Sigma® HP Partial Knee System.
详细描述
This study is an epidemiological Level IV-Case Series clinical study that will study the survivorship of the Sigma® HP Partial Knee System in a consecutive series of patients. All patients who received the Sigma® HP Partial Knee System between August 21, 2008 and October 31, 2009 will be available to include in the study. Data will be collected preoperatively, intra-operatively, and post-operatively at intervals of 6 weeks, 6 months, 1 year, 2 years, and 5 years. Data will be analyzed for survivorship status at the 2- and 5-year follow-up visits. Other data, including functional outcomes, radiographic outcomes, and wear will be analyzed at the 5-year follow-up visit. Subjects will participate in the study for five years after their surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult patient over the age of 18
- •Diagnosis of isolated medial or lateral compartmental osteoarthritis of the knee joint
- •Must have failed conservative treatment and received a unicompartmental knee arthroplasty between August 21, 2008 and October 31,
- •Must have received the Sigma® HP Partial Knee System.
- •Must have received the surgery from Dr. Almand, Dr. Johnson, or Dr. Pickering at Mississippi Sports Medicine and Orthopaedic Center.
- •Must be willing to provide written consent to participate in the study.
- •Subjects who do not have the legal capacity to consent may be enrolled in the study by a Legally Authorized Representative (LAR). The LAR must provide verification that they have the legal authority to represent the subject.
排除标准
- •Did not receive a unicompartmental knee arthroplasty between August 21, 2008 and October 31,
- •Did not receive a unicompartmental knee arthroplasty using the Sigma® HP Partial Knee.
- •Did not receive their unicompartmental knee replacement from Dr. Almand, Dr. Johnson, or Dr. Pickering at Mississippi Sports Medicine and Orthopaedic Center.
- •Subjects lost to follow-up for any reason including, but not limited to: refusal to consent, death, or geographic isolation will also be excluded from the study.
结局指标
主要结局
Five-Year Survivorship
时间窗: Five Years Post-Op
The primary endpoint of the study is to determine the five-year survivorship of the Sigma® HP Partial Knee System with failure defined as revision for any reason.
次要结局
- Radiographic Outcomes(Pre-Operatively, Two and Five-Year Post-Op)
- Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship(Two Years and Five Years Post-Op)
- Functional Outcomes(Five Years Post-Op)
- Adverse Advents(Post-Operatively)