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

Randomized Multicenter Comparative Trial Evaluating the Impact of the ROMTECH PortableConnect Rehabilitation Device on Time to Recovery and Comprehensive Rehabilitation Outcomes Post Unilateral Total Knee Arthroplasty (TKA)

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.

Study Overview

• Status: Recruiting
• Conditions: Joint Pain; Knee Osteoarthritis; Osteoarthritis, Knee; Osteo Arthritis Knee; Knee Arthritis; Knee Pain Chronic; Knee Disease
• Intervention / Treatment: Device: ROMTech PortableConnect; Device: Traditional Rehabilitation and CPM Device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katelyn Rokenbach; Phone Number: 203-663-3202; Email: katelyn.rokenbach@romtech.com
• Study Contact Backup: Name: Janel Shelton; Phone Number: 203-663-3202; Email: janel.shelton@romtech.com

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Recruiting
      • OrthoArizona
      • Contact: Dameon Hahn; Email: dameon.hahn@romtech.com
      • Contact: David Scheck; Email: david.scheck@romtech.com
  • Florida
    • Aventura, Florida, United States, 33180
      • Recruiting
      • Aventura Orthopaedics
      • Contact: Kourtney Trainor; Email: kourtney.trainor@romtech.com
      • Contact: David Scheck, DPT; Email: david.scheck@romtech.com
    • Clearwater, Florida, United States, 33756
      • Recruiting
      • Orthopaedic Associates of West Florida
      • Contact: Michelle MacMillian; Email: michelle.macmillan@romtech.com
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Recruiting
      • Institute of Orthopedic Research and Innovation
      • Contact: Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Recruiting
      • OrthoSouth
      • Contact: Shane Tripod; Email: shane.tripod@romtech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ROMTech PortableConnect; Rehabilitation Using the ROMTech PortableConnect Device	Device: 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.
Active Comparator: Traditional Rehabilitation & Continuous Passive Motion Device; Combination of OPPT and HHPT in conjunction with CPM device usage	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go (TUG) performance	Assessment performed by study team	Screening
Timed up and go (TUG) performance	Assessment performed by study team	Week 4
Timed up and go (TUG) performance	Assessment performed by study team	Week 7 (End of Treatment)
Timed up and go (TUG) performance	Assessment performed by study team	Week 9 (Follow-UP)
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Screening
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Baseline
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Week 1
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Week 2
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Week 3
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Week 4
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Week 5
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Week 6
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Week 7 (End of Treatment)
Knee pain as measured on a 10-point pain scale	Patient reported outcome	Week 9 (Follow-up)
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Screening
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Baseline
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Week 1
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Week 2
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Week 3
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Week 4
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Week 5
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Week 6
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Week 7 (End of Treatment)
Knee swelling	measured using a tape measure to obtain the circumference of the knee	Week 9 (Follow-up)
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Screening
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Baseline
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Week 1
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Week 2
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Week 3
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Week 4
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Week 5
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Week 6
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Week 7 (End of Treatment)
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Patient reported outcome	Week 9 (Follow-up)
Ambulation using the 6 Minute Walk Test (6MWT)	Assessment performed by study team	Screening, Baseline
Ambulation using the 6 Minute Walk Test (6MWT)	Assessment performed by study team	Baseline
Ambulation using the 6 Minute Walk Test (6MWT)	Assessment performed by study team	Week 4
Ambulation using the 6 Minute Walk Test (6MWT)	Assessment performed by study team	Week 7 (End of Treatment)
Ambulation using the 6 Minute Walk Test (6MWT)	Assessment performed by study team	Week 9 (Follow-up)
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Screening
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Baseline
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Week 1
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Week 2
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Week 3
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Week 4
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Week 5
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Week 6
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Week 7 (End of Treatment)
Days to ambulate without assistive devices and/or assistance	Obtained via single response question	Week 9 (Follow-up)
Days to return to activities of daily living	Obtained via patient interview	Screening
Days to return to activities of daily living	Obtained via patient interview	Baseline
Days to return to activities of daily living	Obtained via patient interview	Week 1
Days to return to activities of daily living	Obtained via patient interview	Week 2
Days to return to activities of daily living	Obtained via patient interview	Week 3
Days to return to activities of daily living	Obtained via patient interview	Week 4
Days to return to activities of daily living	Obtained via patient interview	Week 5
Days to return to activities of daily living	Obtained via patient interview	Week 6
Days to return to activities of daily living	Obtained via patient interview	Week 7 (End of Treatment)
Days to return to activities of daily living	Obtained via patient interview	Week 9 (Follow-up)
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Screening
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Baseline
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Week 1
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Week 2
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Week 3
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Week 4
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Week 5
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Week 6
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Week 7 (End of Treatment)
Opioid usage	Compared to baseline opioid use by concomitant medication tracking at each visit	Week 9 (Follow-up)
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Screening
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Baseline
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Week 1
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Week 2
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Week 3
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Week 4
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Week 5
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Week 6
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Week 7 (End of Treatment)
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome	Week 9 (Follow-up)
Oxford Knee Score (OKS)	Patient reported outcome	Screening
Oxford Knee Score (OKS)	Patient reported outcome	Baseline
Oxford Knee Score (OKS)	Patient reported outcome	Week 1
Oxford Knee Score (OKS)	Patient reported outcome	Week 2
Oxford Knee Score (OKS)	Patient reported outcome	Week 3
Oxford Knee Score (OKS)	Patient reported outcome	Week 4
Oxford Knee Score (OKS)	Patient reported outcome	Week 5
Oxford Knee Score (OKS)	Patient reported outcome	Week 6
Oxford Knee Score (OKS)	Patient reported outcome	Week 7 (End of Treatment)
Oxford Knee Score (OKS)	Patient reported outcome	Week 9 (Follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Questionnaire via 4-point scale	Patient Reported Outcome	Week 1
Patient Satisfaction Questionnaire via 4-point scale	Patient Reported Outcome	Week 2
Patient Satisfaction Questionnaire via 4-point scale	Patient Reported Outcome	Week 3
Patient Satisfaction Questionnaire via 4-point scale	Patient Reported Outcome	Week 4
Patient Satisfaction Questionnaire via 4-point scale	Patient Reported Outcome	Week 5
Patient Satisfaction Questionnaire via 4-point scale	Patient Reported Outcome	Week 6
Patient Satisfaction Questionnaire via 4-point scale	Patient Reported Outcome	Week 7 (End of Treatment)
Patient Satisfaction Questionnaire via 4-point scale	Patient Reported Outcome	Week 9 (Follow-up)
Manipulation under anesthesia	By patient questionnaires	Baseline
Manipulation under anesthesia	By patient questionnaires	Week 1
Manipulation under anesthesia	By patient questionnaires	Week 2
Manipulation under anesthesia	By patient questionnaires	Week 3
Manipulation under anesthesia	By patient questionnaires	Week 4
Manipulation under anesthesia	By patient questionnaires	Week 5
Manipulation under anesthesia	By patient questionnaires	Week 6
Manipulation under anesthesia	By patient questionnaires	Week 7 (End of Treatment)
Manipulation under anesthesia	By patient questionnaires	Week 9 (Follow-up)
Total number of physical therapy sessions completed	A sum of all physical therapy sessions outpatient and home health visits	Baseline
Total number of physical therapy sessions completed	A sum of all physical therapy sessions outpatient and home health visits	Week 1
Total number of physical therapy sessions completed	A sum of all physical therapy sessions outpatient and home health visits	Week 2
Total number of physical therapy sessions completed	A sum of all physical therapy sessions outpatient and home health visits	Week 3
Total number of physical therapy sessions completed	A sum of all physical therapy sessions outpatient and home health visits	Week 4
Total number of physical therapy sessions completed	A sum of all physical therapy sessions outpatient and home health visits	Week 5
Total number of physical therapy sessions completed	A sum of all physical therapy sessions outpatient and home health visits	Week 6
Total number of physical therapy sessions completed	A sum of all physical therapy sessions outpatient and home health visits	Week 7 (End of Treatment)
Total number of physical therapy sessions completed	A sum of all physical therapy sessions outpatient and home health visits	Week 9 (Follow-up)

Collaborators and Investigators

• Sponsor: ROM Technologies, INC
• Investigators: Study Director: Ryan Nunley, MD, ROM Tech

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 22, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Osteoarthritis; Physical Therapy; Remote monitoring; Outpatient Physical Therapy; ROMTech; PortableConnect; Home Health Physical Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Arthralgia; Osteoarthritis, Knee
• Other Study ID Numbers: ROMTECH-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No