跳至主要内容
临床试验/NCT05678231
NCT05678231
进行中(未招募)
不适用

Use of the Disposable Zero Degree Knee Postoperative Positioner for Improved Early Knee Extension and Self-Reported Outcomes Following Total Knee Arthroplasty

Prisma Health-Midlands1 个研究点 分布在 1 个国家目标入组 154 人2023年2月10日

概览

阶段
不适用
干预措施
Standard of Care
疾病 / 适应症
Osteoarthritis, Knee
发起方
Prisma Health-Midlands
入组人数
154
试验地点
1
主要终点
Effect of the Zero Degree Knee device on post-operative knee extension in patients at 2 weeks post-op following total knee replacement as measured by lateral radiograph and physician interpretation.
状态
进行中(未招募)
最后更新
2个月前

概览

简要总结

Studies have demonstrated that early rehabilitation interventions following knee arthroplasty (TKA) can shorten the time needed to regain baseline extension/full extension and gait mechanics. As telehealth visits and home-based rehabilitation increases with advancements in technology, much of this rehabilitation is projected to be performed at home. The purpose of this study is to prospectively evaluate early post-operative knee extension and self-reported outcomes in patients using the Zero Degree Knee positioner (ZDK) compared to subjects not using the ZDK. Patients electing to undergo primary TKA will be recruited into the study and randomized to receive and follow the ZDK protocol post-operatively or standard of care rehabilitation instructions. Knee extension measurements will be recorded at 2 weeks post-op and patient-reported outcome measurements will be recorded pre-operatively and at various post-op timepoints.

详细描述

Total Knee Arthroplasty (TKA) remains one of the most commonly performed elective surgical procedures in the United States. The number of TKAs performed annually has increased steadily since 2005 and is projected to be more than 3 million procedures annually by 2030. This steady growth may be attributed to the increasing geriatric population which is expected to represent 17% of the world's population by 2050. TKA aims to reduce pain and restore motion from those with knee complications, and with the geriatric population continuing to rise, TKA procedures are projected to grow over the next decade and beyond. Historically, one of the major concerns following TKA is joint stiffness and subsequent range of motion loss. Range of motion loss, or more specifically, the inability to regain full extension (flexion contracture) have a relatively high occurrence and may lead to gait abnormalities and associated complications of the hips and low back. Early rehabilitation interventions following TKA may shorten the time needed to regain baseline extension/full extension and gait mechanics which not only is this beneficial for patient reported outcomes, but early rehabilitation interventions may reduce the economic burden associated with TKA recovery. In-home or virtual physical therapy (PT) has also helped offload the economic burden to patients following TKA comparted to traditional in-clinic physical therapy. More importantly, the rise in in-home/virtual PT has not compromised patient outcomes, rather, it has improved them. In-home/virtual PT has reported improvements in total cost of therapy, compliance with unsupervised therapy, and hospital readmission rates. Patient positioning has always played a vital role in the effectiveness of postoperative therapy. Historically, a continuous passive motion (CPM) machine was the standard for initiating ROM exercises, however, this modality has fallen out of favor due to the inconsistency of patient position and appropriate fitting of the device. The Zero Degree Knee (ZDK) positioning device is a knee extension pillow designed to simplify knee extension exercise following TKA surgery. Following knee surgery, the patient often experiences postoperative surgical pain which may lead to apprehension to physical therapy and engaging knee musculature. This apprehension may lead to joint stiffness and ultimately, ROM loss. The ZDK is a pillow that elevates the lower extremity and allows gravity to pull the knee passively and gently into an extended position. Additionally, the ZDK has a sliding capability that allows a patient to work on knee extension exercises along with knee flexion exercises. In this study, the investigators aim to prospectively evaluate early post-operative knee extension and self-reported outcomes in patients using the Zero Degree Knee positioner. Patients electing to undergo primary TKA will be recruited into the study and randomized to receive and follow the ZDK protocol post-operatively or standard of care rehabilitation instructions. Knee extension measurements will be recorded at 2 weeks post-op and patient-reported outcome measurements will be recorded pre-operatively and at various post-op timepoints.

注册库
clinicaltrials.gov
开始日期
2023年2月10日
结束日期
2026年6月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Men and women between the ages of 40-80 years
  • Candidate for total knee arthroplasty
  • Diagnosis of mild to advanced osteoarthritis
  • The ability to walk independently at baseline

排除标准

  • History of knee replacement in operative limb (i.e. patients undergoing revision surgery)
  • Neuromuscular/skeletal or connective tissue conditions that can alter gait or joint mechanics (joint infection, gout, rheumatoid arthritis)
  • Pregnant women
  • Prisoners
  • Non-English speakers

研究组 & 干预措施

Standard of Care

Patients will receive standard of care instructions rehabilitation instructions following total knee replacement.

Zero Degree Knee

Patients will receive the Zero Degree Knee device and instructions for use following total knee replacement.

干预措施: Zero Degree Knee Positioner

结局指标

主要结局

Effect of the Zero Degree Knee device on post-operative knee extension in patients at 2 weeks post-op following total knee replacement as measured by lateral radiograph and physician interpretation.

时间窗: 2 weeks

The degree of knee extension at the 2 week post-operative visit will be measured via lateral radiograph interpreted by an orthopedic surgeon.

次要结局

  • Effect of the Zero Degree Knee device on PROMIS Physical Function scores in patients undergoing total knee replacement surgery.(3 months)
  • Effect of the Zero Degree Knee device on PROMIS Pain Interference scores in patients undergoing total knee replacement surgery.(3 months)
  • Effect of the Zero Degree Knee device on KOOS scores in patients undergoing total knee replacement surgery.(3 months)
  • Effect of the Zero Degree Knee device on PROMIS Mobility scores in patients undergoing total knee replacement surgery.(3 months)

研究点 (1)

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