A Phase 4, Prospective, Randomized Trial to Evaluate Postoperative Outcomes in Total Knee Arthroplasy Patients Using the DJO X4 Brace With the Motion Intelligence Platform
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in the Calculated "Knee Society Score"
研究概览
简要总结
This is a single center, investigator initiated clinical trial using a FDA approved, marketed brace called DJO X4. This phase 4, prospective, randomized clinical trial is being conducted to evaluate the use of the X4 knee brace with the Motion Intelligence platform in patients having unilateral TKA. The study is designed to determine if using a "virtual rehabilitation" device leads to enhanced recovery following TKA by improving patient objective and subjective outcome measures.
详细描述
This is a prospective, randomized clinical trial to evaluate the use of the X4 knee brace with the Motion Intelligence platform in patients having unilateral TKA. This brace is a FDA approved, marketed product being used as per the manufacturer's (DJO) marketed indications. This study is designed to determine if using a "virtual rehabilitation" device leads to enhanced recovery following total knee arthroplasty by improving patient objective and subjective outcome measures. These outcomes will be collected using a validated tool called the Knee Society Score (KSS). The KSS is a standard of care tool collected for all TKA patients pre-operatively and postoperatively at the 8 week visit.
Patients will be randomized to one to 4 cohorts:
DJO X4 Brace with Motion Intelligence Platform: Home discharge-Home. Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform.
Control group-Home discharge. Patients randomized to this group will serve as the control group. There will be no changes to the standard of care recovery for a TKA patient.
DJO X4 Brace with Motion Intelligence Platform: Discharge to rehabilitation center. Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 or < 90
- •Able to read and speak in English
- •Patients having a unilateral total knee arthroplasty by Drs. Krauss or Segal
- •Patients with a smart phone and internet able to access the Motion Intelligence Platform
- •Patient is freely able to provide consent
- •Patients willing to comply with the standard of care postoperative visit schedule (2 and 8 weeks)
- •Agree to complete the KSS 2013 version preoperatively and at the 8 week postoperative visit
- •Agree to complete the study required validated System Usability Scale at the 8 week postoperative visit
- •Exclusion Criteria
- •Surgery covered by workman's compensation
- •Physical impairments which in the opinion of the surgeon will effect or limit rehabilitation (e.g.: Multiple Sclerosis, Parkinson's disease)
- •Limited mobility preoperatively requiring the use of a wheelchair
- •Chronic opioid use prior to surgery
- •Alcohol abuse
- •Participation in another clinical trial
- •Cognitive limitations which will interfere with the understanding of the Motion Intelligence platform
- •Requirement for a knee immobilizer postoperatively
排除标准
- 未提供
结局指标
主要结局
Change in the Calculated "Knee Society Score"
时间窗: Preoperatively and 8 weeks postoperatively
Functional outcomes measured by the 2011 "Knee Society Score". The Functional Activities section consists of 4 sub-sections with a total score ranging from 0-100 points. The higher the numerical value the better the outcome. The sub-sections consist of: (1)Walking and Standing 0-30 points (2)Standard Activities 0-30 points (3)Advanced Activities 0-25 points (4)Discretionary Knee Activities 0-15 points.
次要结局
未报告次要终点