Joint Pain, Knee Arthritis, Knee Disease, Knee Osteoarthritis, Knee Pain Chronic, Osteoarthritis, Knee, Osteo Arthritis Knee
Conditions
Keywords
ROMTech, PortableConnect, Osteoarthritis, Remote monitoring, Home Health Physical Therapy, Outpatient Physical Therapy, Rehabilitation, Physical Therapy
Brief summary
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
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.
Interventions
DEVICEROMTech PortableConnect
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.
DEVICETraditional Rehabilitation and CPM 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.
Sponsors
ROM Technologies, INC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | Screening | Knee Flexion and Extension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation using the 6 Minute Walk Test (6MWT) | Screening, Baseline | Assessment performed by study team |
| Opioid usage | Screening | Compared to baseline opioid use by concomitant medication tracking at each visit |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Screening | Patient reported outcome |
| Oxford Knee Score (OKS) | Screening | Patient reported outcome |
| Timed up and go (TUG) performance | Screening | Assessment performed by study team |
| Knee pain as measured on a 10-point pain scale | Screening | Patient reported outcome |
| Knee swelling | Screening | measured using a tape measure to obtain the circumference of the knee |
| Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) | Screening | Patient reported outcome |
| Days to ambulate without assistive devices and/or assistance | Screening | Obtained via single response question |
| Days to return to activities of daily living | Screening | Obtained via patient interview |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total number of physical therapy sessions completed | Baseline | A sum of all physical therapy sessions outpatient and home health visits |
| Manipulation under anesthesia | Baseline | By patient questionnaires |
| Patient Satisfaction Questionnaire via 4-point scale | Week 1 | Patient Reported Outcome |
Countries
United States
Outcome results
None listed