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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2021-12-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ROMTech PortableConnect

Rehabilitation Using the ROMTech PortableConnect Device

Group Type EXPERIMENTAL

ROMTech PortableConnect

Intervention Type 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.

Traditional Rehabilitation & Continuous Passive Motion Device

Combination of OPPT and HHPT in conjunction with CPM device usage

Group Type ACTIVE_COMPARATOR

Traditional Rehabilitation and CPM Device

Intervention Type 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.

Interventions

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ROMTech 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.

Intervention Type DEVICE

Traditional 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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No