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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROMTech PortableConnect | Experimental | Rehabilitation Using the ROMTech PortableConnect Device |
|
| Traditional Rehabilitation & Continuous Passive Motion Device | Active Comparator | Combination of OPPT and HHPT in conjunction with CPM device usage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROMTech PortableConnect | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Questionnaire via 4-point scale | Patient Reported Outcome | Week 1 |
| Patient Satisfaction Questionnaire via 4-point scale | Patient Reported Outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Nunley, MD | ROM Tech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoArizona | Gilbert | Arizona | 85234 | United States | ||
| Aventura Orthopaedics |
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| Traditional Rehabilitation and CPM Device | Device | 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. |
|
Knee Flexion and Extension |
| Week 9 (Follow-up) |
| 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) |
| Week 2 |
| Patient Satisfaction Questionnaire via 4-point scale | Patient Reported Outcome | Week 3 |
| Patient Satisfaction Questionnaire via 4-point scale | Patient Reported Outcome | Week 4 |
| Patient Satisfaction Questionnaire via 4-point scale | Patient Reported Outcome | Week 5 |
| Patient Satisfaction Questionnaire via 4-point scale | Patient Reported Outcome | Week 6 |
| Patient Satisfaction Questionnaire via 4-point scale | Patient Reported Outcome | Week 7 (End of Treatment) |
| Patient Satisfaction Questionnaire via 4-point scale | Patient Reported Outcome | Week 9 (Follow-up) |
| Manipulation under anesthesia | By patient questionnaires | Baseline |
| Manipulation under anesthesia | By patient questionnaires | Week 1 |
| Manipulation under anesthesia | By patient questionnaires | Week 2 |
| Manipulation under anesthesia | By patient questionnaires | Week 3 |
| Manipulation under anesthesia | By patient questionnaires | Week 4 |
| Manipulation under anesthesia | By patient questionnaires | Week 5 |
| Manipulation under anesthesia | By patient questionnaires | Week 6 |
| Manipulation under anesthesia | By patient questionnaires | Week 7 (End of Treatment) |
| Manipulation under anesthesia | By patient questionnaires | Week 9 (Follow-up) |
| Total number of physical therapy sessions completed | A sum of all physical therapy sessions outpatient and home health visits | Baseline |
| Total number of physical therapy sessions completed | A sum of all physical therapy sessions outpatient and home health visits | Week 1 |
| Total number of physical therapy sessions completed | A sum of all physical therapy sessions outpatient and home health visits | Week 2 |
| Total number of physical therapy sessions completed | A sum of all physical therapy sessions outpatient and home health visits | Week 3 |
| Total number of physical therapy sessions completed | A sum of all physical therapy sessions outpatient and home health visits | Week 4 |
| Total number of physical therapy sessions completed | A sum of all physical therapy sessions outpatient and home health visits | Week 5 |
| Total number of physical therapy sessions completed | A sum of all physical therapy sessions outpatient and home health visits | Week 6 |
| Total number of physical therapy sessions completed | A sum of all physical therapy sessions outpatient and home health visits | Week 7 (End of Treatment) |
| Total number of physical therapy sessions completed | A sum of all physical therapy sessions outpatient and home health visits | Week 9 (Follow-up) |
| Aventura |
| Florida |
| 33180 |
| United States |
| Orthopaedic Associates of West Florida | Clearwater | Florida | 33756 | United States |
| Institute of Orthopedic Research and Innovation | Coeur d'Alene | Idaho | 83814 | United States |
| OrthoSouth | Memphis | Tennessee | 38119 | United States |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D018771 | Arthralgia |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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