ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic, Knee Disease, Joint Pain, Osteo Arthritis Knee, Osteoarthritis, Knee

Intervention / Treatment
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* Device: ROMTech PortableConnect
* Device: Traditional Rehabilitation and CPM Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROMTech PortableConnect<br>Rehabilitation Using the ROMTech PortableConnect Device | Device: ROMTech PortableConnect<br>* ROMTech PortableConnect (ROMTechPC) therapy will be completed four to five times per day for 6 minutes duration for 6 weeks. The intervention will be administered using the portable rehabilitation unit.<br>|
| Active Comparator: Traditional Rehabilitation & Continuous Passive Motion Device<br>Combination of OPPT and HHPT in conjunction with CPM device usage | Device: Traditional Rehabilitation and CPM Device<br>* Continuous passive motion (CPM) with standard of care HHPT and OPPT rehabilitation program (CPM with SOC). Therapy with the CPM will be completed daily from day 0 through week 3 for a total of 6 to 8 hours per day. The HHPT and OPPT rehabilitation program will be a 6-week program based on SOC goals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Knee Flexion and Extension | Screening | 
| Range of Motion | Knee Flexion and Extension | Baseline | 
| Range of Motion | Knee Flexion and Extension | Week 1 | 
| Range of Motion | Knee Flexion and Extension | Week 2 | 
| Range of Motion | Knee Flexion and Extension | Week 3 | 
| Range of Motion | Knee Flexion and Extension | Week 4 | 
| Range of Motion | Knee Flexion and Extension | Week 5 | 
| Range of Motion | Knee Flexion and Extension | Week 6 | 
| Range of Motion | Knee Flexion and Extension | Week 7 (End of Treatment) | 
| Range of Motion | Knee Flexion and Extension | Week 9 (Follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed up and go (TUG) performance | Assessment performed by study team | Screening | 
| Timed up and go (TUG) performance | Assessment performed by study team | Week 4 | 
| Timed up and go (TUG) performance | Assessment performed by study team | Week 7 (End of Treatment) | 
| Timed up and go (TUG) performance | Assessment performed by study team | Week 9 (Follow-UP) | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Screening | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Baseline | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Week 1 | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Week 2 | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Week 3 | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Week 4 | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Week 5 | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Week 6 | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Week 7 (End of Treatment) | 
| Knee pain as measured on a 10-point pain scale | Patient reported outcome | Week 9 (Follow-up) | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Screening | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Baseline | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Week 1 | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Week 2 | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Week 3 | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Week 4 | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Week 5 | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Week 6 | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Week 7 (End of Treatment) | 
| Knee swelling | measured using a tape measure to obtain the circumference of the knee | Week 9 (Follow-up) | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Screening | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Baseline | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Week 1 | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Week 2 | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Week 3 | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Week 4 | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Week 5 | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Week 6 | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Week 7 (End of Treatment) | 
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Patient reported outcome | Week 9 (Follow-up) | 
| Ambulation using the 6 Minute Walk Test (6MWT) | Assessment performed by study team | Screening, Baseline | 
| Ambulation using the 6 Minute Walk Test (6MWT) | Assessment performed by study team | Baseline | 
| Ambulation using the 6 Minute Walk Test (6MWT) | Assessment performed by study team | Week 4 | 
| Ambulation using the 6 Minute Walk Test (6MWT) | Assessment performed by study team | Week 7 (End of Treatment) | 
| Ambulation using the 6 Minute Walk Test (6MWT) | Assessment performed by study team | Week 9 (Follow-up) | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Screening | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Baseline | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Week 1 | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Week 2 | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Week 3 | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Week 4 | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Week 5 | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Week 6 | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Week 7 (End of Treatment) | 
| Days to ambulate without assistive devices and/or assistance | Obtained via single response question | Week 9 (Follow-up) | 
| Days to return to activities of daily living | Obtained via patient interview | Screening | 
| Days to return to activities of daily living | Obtained via patient interview | Baseline | 
| Days to return to activities of daily living | Obtained via patient interview | Week 1 | 
| Days to return to activities of daily living | Obtained via patient interview | Week 2 | 
| Days to return to activities of daily living | Obtained via patient interview | Week 3 | 
| Days to return to activities of daily living | Obtained via patient interview | Week 4 | 
| Days to return to activities of daily living | Obtained via patient interview | Week 5 | 
| Days to return to activities of daily living | Obtained via patient interview | Week 6 | 
| Days to return to activities of daily living | Obtained via patient interview | Week 7 (End of Treatment) | 
| Days to return to activities of daily living | Obtained via patient interview | Week 9 (Follow-up) | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Screening | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Baseline | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Week 1 | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Week 2 | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Week 3 | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Week 4 | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Week 5 | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Week 6 | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Week 7 (End of Treatment) | 
| Opioid usage | Compared to baseline opioid use by concomitant medication tracking at each visit | Week 9 (Follow-up) | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Screening | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Baseline | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Week 1 | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Week 2 | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Week 3 | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Week 4 | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Week 5 | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Week 6 | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Week 7 (End of Treatment) | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome | Week 9 (Follow-up) | 
| Oxford Knee Score (OKS) | Patient reported outcome | Screening | 
| Oxford Knee Score (OKS) | Patient reported outcome | Baseline | 
| Oxford Knee Score (OKS) | Patient reported outcome | Week 1 | 
| Oxford Knee Score (OKS) | Patient reported outcome | Week 2 | 
| Oxford Knee Score (OKS) | Patient reported outcome | Week 3 | 
| Oxford Knee Score (OKS) | Patient reported outcome | Week 4 | 
| Oxford Knee Score (OKS) | Patient reported outcome | Week 5 | 
| Oxford Knee Score (OKS) | Patient reported outcome | Week 6 | 
| Oxford Knee Score (OKS) | Patient reported outcome | Week 7 (End of Treatment) | 
| Oxford Knee Score (OKS) | Patient reported outcome | Week 9 (Follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROMTech, PortableConnect, Osteoarthritis, Remote monitoring, Home Health Physical Therapy, Outpatient Physical Therapy, Rehabilitation, Physical Therapy