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

NCT04497129 | Completed FDA Device

• 1 other identifier: ROMTECH-0002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

ROMTech; PortableConnect; Osteoarthritis; Remote monitoring; Home Health Physical Therapy; Outpatient Physical Therapy; Rehabilitation; Physical Therapy

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (89)

• Timed up and go (TUG) performance

  Screening

• Timed up and go (TUG) performance

  Week 4

• Timed up and go (TUG) performance

  Week 7 (End of Treatment)

• Timed up and go (TUG) performance

  Week 9 (Follow-UP)

• Knee pain as measured on a 10-point pain scale

  Screening

Other Outcomes (26)

• Patient Satisfaction Questionnaire via 4-point scale

  Week 1

• Patient Satisfaction Questionnaire via 4-point scale

  Week 2

• Patient Satisfaction Questionnaire via 4-point scale

  Week 3

Study Arms (2)

ROMTech PortableConnect

EXPERIMENTAL

Rehabilitation Using the ROMTech PortableConnect Device

Device: ROMTech PortableConnect

Traditional Rehabilitation & Continuous Passive Motion Device

ACTIVE COMPARATOR

Combination of OPPT and HHPT in conjunction with CPM device usage

Device: Traditional Rehabilitation and CPM Device

Interventions

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.

ROMTech PortableConnect

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.

Traditional Rehabilitation & Continuous Passive Motion Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ROM Technologies, INC: lead

Study Sites (5)

OrthoArizona

Gilbert, Arizona, 85234, United States

Location

Aventura Orthopaedics

Aventura, Florida, 33180, United States

Location

Orthopaedic Associates of West Florida

Clearwater, Florida, 33756, United States

Location

Institute of Orthopedic Research and Innovation

Coeur d'Alene, Idaho, 83814, United States

Location

OrthoSouth

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthralgia; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan Nunley, MD

  ROM Tech

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: August 4, 2020
• Study Start: August 17, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)