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临床试验/NCT03328611
NCT03328611招募中不适用

MCJR Joint Replacement Clinical Outcomes Database

Midwest Center for Joint Replacement1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
KOOS

研究概览

简要总结

The purpose of this research study is to develop a database of information regarding the diagnosis, treatment, and outcome of participants who have had a joint replacement. The more information gathered, the better the investigators will be able to treat future patients who need a joint replacement. For example the investigators learn what works well to help design implants and treatment protocols for the future. The investigators publish manuscripts and present research findings around the world to help other investigators and clinicians learn what is discovered. Furthermore, implant manufacturers may be able to use this information in the database to evaluate the success rates of specific joint replacement products.

详细描述

As part of our growing clinical tracking EMR system the investigators plan to collect preoperative and postoperative Patient Reported Outcome Measures (PROMS) on all patients with degenerative hip and knee disease. The investigators will collect PROMS along with implant device specific revision rates. This will be used for implant surveillance, clinical outcome tracking, return to work outcome metrics and failure modes and rates of various hip and knee implants. Information generated during regular hospital and clinic visits will be entered into the database. For example, x-ray findings done before surgery will be entered into the database. Surgery information will be entered into the database. The investigators will also enter demographic information into the database such as name, email, birthdate, gender, height, and weight. Medical co-morbidities such as diabetes, high blood pressure, and prior surgeries will also be entered.

The investigators will collect this information before surgery, during the operation, and at annual follow-up visits. The investigators will also contact patients via email with short outcome score surveys (known as Patient Reported Outcome Measures or PROM's). This will save many hours of return visits if scores indicate the joint replacements are doing well. Also this will trigger additional follow-up measures if PROMS scores drop off.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of degenerative joint disease requiring treatment with a joint replacement

排除标准

  • Clinical diagnosis of degenerative joint disease not requiring treatment with a joint replacement

结局指标

主要结局

KOOS

时间窗: Change in HOOS from Baseline at 1 year, assessed up to 30 years

Knee Outcome scores

Oxford Knee Score

时间窗: Change in OKS from Baseline at 1 year, assessed up to 30 years

OKS - PROM

HOOS

时间窗: Change in HOOS from Baseline at 1 year, assessed up to 30 years

Hip Outcome scores

次要结局

  • radiographic findings(Change in radiographic findings from Baseline at 1 year, assessed up to 30 years)

研究者

发起方
Midwest Center for Joint Replacement
申办方类型
Other
责任方
Sponsor

研究点 (1)

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