An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Changes in the ankle joint space width
研究概览
简要总结
The immediate goal of the proposed research is to test the value of a new low-cost, low-dose standing CT system for efficient early detection of both joint degeneration and elevated contact stress. The standing CT scanner holds promise for detecting arthritic changes earlier than other imaging modalities because of the combination of its 3D nature and ability to image joints in a weight-bearing pose. A secondary goal of the proposed research is to enable predictive models for osteoarthritis risk based on measures of post treatment contact stress, both to inform treatment and so that new interventions can be tested in a manner incorporating risk stratification.
详细描述
Individuals who present with an intra-articular of the tibial plafond will be consented to participate in this study. We will obtain pedCAT scans at 6, 12, and 18 months post-injury, as well as several questionnaires that will be administered during the clinical visits. We will also review the subjects' electronic medical record for data related to the injury, including the timing and mechanism of injury, time from injury to surgery, length of hospital stay, any complications and/or subsequent ankle surgeries, as well as any clinic notes, imaging, and/or outcomes scores related to the calcaneus fracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals 18 to 70 years old Sustained an intra-articular fracture of the tibial plafond Indicated for operative treatment Present for treatment within 4 weeks of injury
排除标准
- •Women who are pregnant or planning on becoming pregnant Individuals younger than 18 and older than 70
研究组 & 干预措施
Experimental: pedCAT
Subjects will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury.
Additional funding was secured and follow-up for subjects initially enrolled under OTA funding was extended to include yearly follow-up through 5 years post ankle injury
干预措施: pedCAT (Radiation)
结局指标
主要结局
Changes in the ankle joint space width
时间窗: 18 months
Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging compared to baseline pedCAT imaging
Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up
时间窗: Final imaging assessed at 18 months or up to 5 years post-injury
Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging at the final follow-up visit using contralateral, uninjured side as control. Final follow-up occurred at 18 month follow-up or at 5 years follow-up.
次要结局
- Change in ankle function(18 months)
- Change in ankle pain(18 months)
- Change in Ankle Pain(final follow-up occurred at either 18 months or up to 5 years post-injury)
- Change in Ankle Function(18 months or up to 5 years post-injury)
研究者
J L Marsh
Professor
University of Iowa