Randomized Multicenter Comparative Trial Evaluating the Impact of the ROMTECH PortableConnect Rehabilitation Device on Time to Recovery and Comprehensive Rehabilitation Outcomes Post Unilateral Total Knee Arthroplasty (TKA)
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
- 5
- 主要终点
- Range of Motion
研究概览
简要总结
ROMTech is focused on transforming the healthcare market by delivering lower extremity rehabilitation systems that are effective, efficient for patient use, cost-effective, and provide better patient outcomes while simultaneously decreasing rehabilitation and overall recovery times.
详细描述
The patented technology of the ROMTech PortableConnect can improve the rehabilitation protocol for lower extremities in shorter time periods. The focus of this study is to compare the effectiveness of the ROMTech PortableConncect device only rehabilitation program following total knee arthroplasty to an active comparator group of continuous passive motion with a standard of care combination HHPT and OPPT rehabilitation program. The technology used to develop the ROMTech PortableConnect device has been reported in a pilot study to tend to be highly effective in decreasing the recovery time of patients post TKA, as discussed in the findings from the pilot study with the ROMTech Pro Cycle. The expedited recovery resulting from use of the ROMTech rehabilitation technology is noted to be contributed to the ability of the ROMTech technology to achieve a more rapid range of motion in this patient population.
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
- Double (Participant, Outcomes Assessor)
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
- •Male or female ≥18 years of age at screening visit.
- •Documentation of a definitive diagnosis of osteoarthritis of the knee requiring total knee arthroplasty.
- •Scheduled or willing to schedule TKA procedure within the timelines consistent with the study enrollment period. This includes up to a 28-day screening window prior to the scheduled surgery.
- •Willing to consent to outpatient, home-based physical therapy, CPM, or the ROMTech protocol
- •Able to provide written informed consent.
- •Willing and able to participate in and complete all study assessments, questionnaires, and procedure
排除标准
- •Inability to provide informed consent.
- •Inability to understand and complete study related assessments and procedures.
- •Other scheduled surgical knee procedures in addition to the TKA.
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
- •History of musculoskeletal or neurological disorders that limit physical function including but not limited to severe spine OA, contralateral leg issues limiting mobility, and other disorders as identified by the investigator
- •Planned additional knee joint surgery within 3 months of the primary scheduled TKA
研究组 & 干预措施
ROMTech PortableConnect
Rehabilitation Using the ROMTech PortableConnect Device
干预措施: ROMTech PortableConnect (Device)
Traditional Rehabilitation & Continuous Passive Motion Device
Combination of OPPT and HHPT in conjunction with CPM device usage
干预措施: Traditional Rehabilitation and CPM Device (Device)
结局指标
主要结局
Range of Motion
时间窗: Week 9 (Follow-up)
Knee Flexion and Extension
Range of Motion
时间窗: Week 5
Knee Flexion and Extension
Range of Motion
时间窗: Week 4
Knee Flexion and Extension
Range of Motion
时间窗: Screening
Knee Flexion and Extension
Range of Motion
时间窗: Baseline
Knee Flexion and Extension
Range of Motion
时间窗: Week 1
Knee Flexion and Extension
Range of Motion
时间窗: Week 2
Knee Flexion and Extension
Range of Motion
时间窗: Week 3
Knee Flexion and Extension
Range of Motion
时间窗: Week 6
Knee Flexion and Extension
Range of Motion
时间窗: Week 7 (End of Treatment)
Knee Flexion and Extension
次要结局
- Days to ambulate without assistive devices and/or assistance(Week 9 (Follow-up))
- Timed up and go (TUG) performance(Week 9 (Follow-UP))
- Knee swelling(Week 9 (Follow-up))
- Ambulation using the 6 Minute Walk Test (6MWT)(Week 9 (Follow-up))
- Knee pain as measured on a 10-point pain scale(Week 9 (Follow-up))
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Week 9 (Follow-up))
- Days to return to activities of daily living(Week 9 (Follow-up))
- Oxford Knee Score (OKS)(Week 9 (Follow-up))
- Opioid usage(Week 9 (Follow-up))
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Week 9 (Follow-up))
- Timed up and go (TUG) performance(Screening)
- Timed up and go (TUG) performance(Week 4)
- Timed up and go (TUG) performance(Week 7 (End of Treatment))
- Knee pain as measured on a 10-point pain scale(Screening)
- Knee pain as measured on a 10-point pain scale(Baseline)
- Knee pain as measured on a 10-point pain scale(Week 1)
- Knee pain as measured on a 10-point pain scale(Week 2)
- Knee pain as measured on a 10-point pain scale(Week 3)
- Knee pain as measured on a 10-point pain scale(Week 4)
- Knee pain as measured on a 10-point pain scale(Week 5)
- Knee pain as measured on a 10-point pain scale(Week 6)
- Knee pain as measured on a 10-point pain scale(Week 7 (End of Treatment))
- Knee swelling(Screening)
- Knee swelling(Baseline)
- Knee swelling(Week 1)
- Knee swelling(Week 2)
- Knee swelling(Week 3)
- Knee swelling(Week 4)
- Knee swelling(Week 5)
- Knee swelling(Week 6)
- Knee swelling(Week 7 (End of Treatment))
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Screening)
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Baseline)
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Week 1)
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Week 2)
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Week 3)
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Week 4)
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Week 5)
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Week 6)
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)(Week 7 (End of Treatment))
- Ambulation using the 6 Minute Walk Test (6MWT)(Screening, Baseline)
- Ambulation using the 6 Minute Walk Test (6MWT)(Baseline)
- Ambulation using the 6 Minute Walk Test (6MWT)(Week 4)
- Ambulation using the 6 Minute Walk Test (6MWT)(Week 7 (End of Treatment))
- Days to ambulate without assistive devices and/or assistance(Screening)
- Days to ambulate without assistive devices and/or assistance(Baseline)
- Days to ambulate without assistive devices and/or assistance(Week 1)
- Days to ambulate without assistive devices and/or assistance(Week 2)
- Days to ambulate without assistive devices and/or assistance(Week 3)
- Days to ambulate without assistive devices and/or assistance(Week 4)
- Days to ambulate without assistive devices and/or assistance(Week 5)
- Days to ambulate without assistive devices and/or assistance(Week 6)
- Days to ambulate without assistive devices and/or assistance(Week 7 (End of Treatment))
- Days to return to activities of daily living(Screening)
- Days to return to activities of daily living(Baseline)
- Days to return to activities of daily living(Week 1)
- Days to return to activities of daily living(Week 2)
- Days to return to activities of daily living(Week 3)
- Days to return to activities of daily living(Week 4)
- Days to return to activities of daily living(Week 5)
- Days to return to activities of daily living(Week 6)
- Days to return to activities of daily living(Week 7 (End of Treatment))
- Opioid usage(Screening)
- Opioid usage(Baseline)
- Opioid usage(Week 1)
- Opioid usage(Week 2)
- Opioid usage(Week 3)
- Opioid usage(Week 4)
- Opioid usage(Week 5)
- Opioid usage(Week 6)
- Opioid usage(Week 7 (End of Treatment))
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Screening)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Week 1)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Week 2)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Week 3)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Week 4)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Week 5)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Week 6)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Week 7 (End of Treatment))
- Oxford Knee Score (OKS)(Screening)
- Oxford Knee Score (OKS)(Baseline)
- Oxford Knee Score (OKS)(Week 1)
- Oxford Knee Score (OKS)(Week 2)
- Oxford Knee Score (OKS)(Week 3)
- Oxford Knee Score (OKS)(Week 4)
- Oxford Knee Score (OKS)(Week 5)
- Oxford Knee Score (OKS)(Week 6)
- Oxford Knee Score (OKS)(Week 7 (End of Treatment))