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

ROM Technologies

Status: Unknown

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

Treatments: Device: ROMTech PortableConnect; Device: Traditional Rehabilitation and CPM Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04497129

ROMTECH-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

ROMTech PortableConnect

Experimental group

Description:

Rehabilitation Using the ROMTech PortableConnect Device

Treatment:

Device: ROMTech PortableConnect

Traditional Rehabilitation & Continuous Passive Motion Device

Active Comparator group

Description:

Combination of OPPT and HHPT in conjunction with CPM device usage

Treatment:

Device: Traditional Rehabilitation and CPM Device