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

Last updated: May 22, 2021
Sponsor: ROM Technologies, INC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Arthritis And Arthritic Pain (Pediatric)

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT04497129
ROMTECH-0002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female ≥18 years of age at screening visit.
  • Documentation of a definitive diagnosis of osteoarthritis of the knee requiring totalknee arthroplasty.
  • Scheduled or willing to schedule TKA procedure within the timelines consistent withthe study enrollment period. This includes up to a 28-day screening window prior tothe scheduled surgery.
  • Willing to consent to outpatient, home-based physical therapy, CPM, or the ROMTechprotocol
  • Able to provide written informed consent.
  • Willing and able to participate in and complete all study assessments, questionnaires,and procedure

Exclusion

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 wouldcompromise the safety of the subject or the quality of the data.
  • History of musculoskeletal or neurological disorders that limit physical functionincluding but not limited to severe spine OA, contralateral leg issues limitingmobility, and other disorders as identified by the investigator
  • Planned additional knee joint surgery within 3 months of the primary scheduled TKA

Study Design

Total Participants: 300
Study Start date:
August 17, 2020
Estimated Completion Date:
March 31, 2022

Study 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.

Connect with a study center

  • OrthoArizona

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • Aventura Orthopaedics

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Orthopaedic Associates of West Florida

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Institute of Orthopedic Research and Innovation

    Coeur d'Alene, Idaho 83814
    United States

    Active - Recruiting

  • OrthoSouth

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

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