Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497129
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
ROM Technologies, INC

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Knee Arthritis Knee Pain Chronic Knee Disease Joint Pain Osteo Arthritis Knee Osteoarthritis, Knee Device: ROMTech PortableConnect Device: Traditional Rehabilitation and CPM Device Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 17, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Range of Motion [ Time Frame: Screening ]
    Knee Flexion and Extension

  2. Range of Motion [ Time Frame: Baseline ]
    Knee Flexion and Extension

  3. Range of Motion [ Time Frame: Week 1 ]
    Knee Flexion and Extension

  4. Range of Motion [ Time Frame: Week 2 ]
    Knee Flexion and Extension

  5. Range of Motion [ Time Frame: Week 3 ]
    Knee Flexion and Extension

  6. Range of Motion [ Time Frame: Week 4 ]
    Knee Flexion and Extension

  7. Range of Motion [ Time Frame: Week 5 ]
    Knee Flexion and Extension

  8. Range of Motion [ Time Frame: Week 6 ]
    Knee Flexion and Extension

  9. Range of Motion [ Time Frame: Week 7 (End of Treatment) ]
    Knee Flexion and Extension

  10. Range of Motion [ Time Frame: Week 9 (Follow-up) ]
    Knee Flexion and Extension


Secondary Outcome Measures :
  1. Timed up and go (TUG) performance [ Time Frame: Screening ]
    Assessment performed by study team

  2. Timed up and go (TUG) performance [ Time Frame: Week 4 ]
    Assessment performed by study team

  3. Timed up and go (TUG) performance [ Time Frame: Week 7 (End of Treatment) ]
    Assessment performed by study team

  4. Timed up and go (TUG) performance [ Time Frame: Week 9 (Follow-UP) ]
    Assessment performed by study team

  5. Knee pain as measured on a 10-point pain scale [ Time Frame: Screening ]
    Patient reported outcome

  6. Knee pain as measured on a 10-point pain scale [ Time Frame: Baseline ]
    Patient reported outcome

  7. Knee pain as measured on a 10-point pain scale [ Time Frame: Week 1 ]
    Patient reported outcome

  8. Knee pain as measured on a 10-point pain scale [ Time Frame: Week 2 ]
    Patient reported outcome

  9. Knee pain as measured on a 10-point pain scale [ Time Frame: Week 3 ]
    Patient reported outcome

  10. Knee pain as measured on a 10-point pain scale [ Time Frame: Week 4 ]
    Patient reported outcome

  11. Knee pain as measured on a 10-point pain scale [ Time Frame: Week 5 ]
    Patient reported outcome

  12. Knee pain as measured on a 10-point pain scale [ Time Frame: Week 6 ]
    Patient reported outcome

  13. Knee pain as measured on a 10-point pain scale [ Time Frame: Week 7 (End of Treatment) ]
    Patient reported outcome

  14. Knee pain as measured on a 10-point pain scale [ Time Frame: Week 9 (Follow-up) ]
    Patient reported outcome

  15. Knee swelling [ Time Frame: Screening ]
    measured using a tape measure to obtain the circumference of the knee

  16. Knee swelling [ Time Frame: Baseline ]
    measured using a tape measure to obtain the circumference of the knee

  17. Knee swelling [ Time Frame: Week 1 ]
    measured using a tape measure to obtain the circumference of the knee

  18. Knee swelling [ Time Frame: Week 2 ]
    measured using a tape measure to obtain the circumference of the knee

  19. Knee swelling [ Time Frame: Week 3 ]
    measured using a tape measure to obtain the circumference of the knee

  20. Knee swelling [ Time Frame: Week 4 ]
    measured using a tape measure to obtain the circumference of the knee

  21. Knee swelling [ Time Frame: Week 5 ]
    measured using a tape measure to obtain the circumference of the knee

  22. Knee swelling [ Time Frame: Week 6 ]
    measured using a tape measure to obtain the circumference of the knee

  23. Knee swelling [ Time Frame: Week 7 (End of Treatment) ]
    measured using a tape measure to obtain the circumference of the knee

  24. Knee swelling [ Time Frame: Week 9 (Follow-up) ]
    measured using a tape measure to obtain the circumference of the knee

  25. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Screening ]
    Patient reported outcome

  26. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Baseline ]
    Patient reported outcome

  27. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 1 ]
    Patient reported outcome

  28. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 2 ]
    Patient reported outcome

  29. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 3 ]
    Patient reported outcome

  30. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 4 ]
    Patient reported outcome

  31. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 5 ]
    Patient reported outcome

  32. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 6 ]
    Patient reported outcome

  33. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 7 (End of Treatment) ]
    Patient reported outcome

  34. Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 9 (Follow-up) ]
    Patient reported outcome

  35. Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Screening, Baseline ]
    Assessment performed by study team

  36. Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Baseline ]
    Assessment performed by study team

  37. Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Week 4 ]
    Assessment performed by study team

  38. Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Week 7 (End of Treatment) ]
    Assessment performed by study team

  39. Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Week 9 (Follow-up) ]
    Assessment performed by study team

  40. Days to ambulate without assistive devices and/or assistance [ Time Frame: Screening ]
    Obtained via single response question

  41. Days to ambulate without assistive devices and/or assistance [ Time Frame: Baseline ]
    Obtained via single response question

  42. Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 1 ]
    Obtained via single response question

  43. Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 2 ]
    Obtained via single response question

  44. Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 3 ]
    Obtained via single response question

  45. Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 4 ]
    Obtained via single response question

  46. Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 5 ]
    Obtained via single response question

  47. Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 6 ]
    Obtained via single response question

  48. Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 7 (End of Treatment) ]
    Obtained via single response question

  49. Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 9 (Follow-up) ]
    Obtained via single response question

  50. Days to return to activities of daily living [ Time Frame: Screening ]
    Obtained via patient interview

  51. Days to return to activities of daily living [ Time Frame: Baseline ]
    Obtained via patient interview

  52. Days to return to activities of daily living [ Time Frame: Week 1 ]
    Obtained via patient interview

  53. Days to return to activities of daily living [ Time Frame: Week 2 ]
    Obtained via patient interview

  54. Days to return to activities of daily living [ Time Frame: Week 3 ]
    Obtained via patient interview

  55. Days to return to activities of daily living [ Time Frame: Week 4 ]
    Obtained via patient interview

  56. Days to return to activities of daily living [ Time Frame: Week 5 ]
    Obtained via patient interview

  57. Days to return to activities of daily living [ Time Frame: Week 6 ]
    Obtained via patient interview

  58. Days to return to activities of daily living [ Time Frame: Week 7 (End of Treatment) ]
    Obtained via patient interview

  59. Days to return to activities of daily living [ Time Frame: Week 9 (Follow-up) ]
    Obtained via patient interview

  60. Opioid usage [ Time Frame: Screening ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  61. Opioid usage [ Time Frame: Baseline ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  62. Opioid usage [ Time Frame: Week 1 ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  63. Opioid usage [ Time Frame: Week 2 ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  64. Opioid usage [ Time Frame: Week 3 ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  65. Opioid usage [ Time Frame: Week 4 ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  66. Opioid usage [ Time Frame: Week 5 ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  67. Opioid usage [ Time Frame: Week 6 ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  68. Opioid usage [ Time Frame: Week 7 (End of Treatment) ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  69. Opioid usage [ Time Frame: Week 9 (Follow-up) ]
    Compared to baseline opioid use by concomitant medication tracking at each visit

  70. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Screening ]
    Patient reported outcome

  71. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline ]
    Patient reported outcome

  72. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 1 ]
    Patient reported outcome

  73. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 2 ]
    Patient reported outcome

  74. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 3 ]
    Patient reported outcome

  75. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 4 ]
    Patient reported outcome

  76. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 5 ]
    Patient reported outcome

  77. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 6 ]
    Patient reported outcome

  78. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 7 (End of Treatment) ]
    Patient reported outcome

  79. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 9 (Follow-up) ]
    Patient reported outcome

  80. Oxford Knee Score (OKS) [ Time Frame: Screening ]
    Patient reported outcome

  81. Oxford Knee Score (OKS) [ Time Frame: Baseline ]
    Patient reported outcome

  82. Oxford Knee Score (OKS) [ Time Frame: Week 1 ]
    Patient reported outcome

  83. Oxford Knee Score (OKS) [ Time Frame: Week 2 ]
    Patient reported outcome

  84. Oxford Knee Score (OKS) [ Time Frame: Week 3 ]
    Patient reported outcome

  85. Oxford Knee Score (OKS) [ Time Frame: Week 4 ]
    Patient reported outcome

  86. Oxford Knee Score (OKS) [ Time Frame: Week 5 ]
    Patient reported outcome

  87. Oxford Knee Score (OKS) [ Time Frame: Week 6 ]
    Patient reported outcome

  88. Oxford Knee Score (OKS) [ Time Frame: Week 7 (End of Treatment) ]
    Patient reported outcome

  89. Oxford Knee Score (OKS) [ Time Frame: Week 9 (Follow-up) ]
    Patient reported outcome


Other Outcome Measures:
  1. Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 1 ]
    Patient Reported Outcome

  2. Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 2 ]
    Patient Reported Outcome

  3. Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 3 ]
    Patient Reported Outcome

  4. Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 4 ]
    Patient Reported Outcome

  5. Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 5 ]
    Patient Reported Outcome

  6. Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 6 ]
    Patient Reported Outcome

  7. Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 7 (End of Treatment) ]
    Patient Reported Outcome

  8. Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 9 (Follow-up) ]
    Patient Reported Outcome

  9. Manipulation under anesthesia [ Time Frame: Baseline ]
    By patient questionnaires

  10. Manipulation under anesthesia [ Time Frame: Week 1 ]
    By patient questionnaires

  11. Manipulation under anesthesia [ Time Frame: Week 2 ]
    By patient questionnaires

  12. Manipulation under anesthesia [ Time Frame: Week 3 ]
    By patient questionnaires

  13. Manipulation under anesthesia [ Time Frame: Week 4 ]
    By patient questionnaires

  14. Manipulation under anesthesia [ Time Frame: Week 5 ]
    By patient questionnaires

  15. Manipulation under anesthesia [ Time Frame: Week 6 ]
    By patient questionnaires

  16. Manipulation under anesthesia [ Time Frame: Week 7 (End of Treatment) ]
    By patient questionnaires

  17. Manipulation under anesthesia [ Time Frame: Week 9 (Follow-up) ]
    By patient questionnaires

  18. Total number of physical therapy sessions completed [ Time Frame: Baseline ]
    A sum of all physical therapy sessions outpatient and home health visits

  19. Total number of physical therapy sessions completed [ Time Frame: Week 1 ]
    A sum of all physical therapy sessions outpatient and home health visits

  20. Total number of physical therapy sessions completed [ Time Frame: Week 2 ]
    A sum of all physical therapy sessions outpatient and home health visits

  21. Total number of physical therapy sessions completed [ Time Frame: Week 3 ]
    A sum of all physical therapy sessions outpatient and home health visits

  22. Total number of physical therapy sessions completed [ Time Frame: Week 4 ]
    A sum of all physical therapy sessions outpatient and home health visits

  23. Total number of physical therapy sessions completed [ Time Frame: Week 5 ]
    A sum of all physical therapy sessions outpatient and home health visits

  24. Total number of physical therapy sessions completed [ Time Frame: Week 6 ]
    A sum of all physical therapy sessions outpatient and home health visits

  25. Total number of physical therapy sessions completed [ Time Frame: Week 7 (End of Treatment) ]
    A sum of all physical therapy sessions outpatient and home health visits

  26. Total number of physical therapy sessions completed [ Time Frame: Week 9 (Follow-up) ]
    A sum of all physical therapy sessions outpatient and home health visits


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497129


Contacts
Layout table for location contacts
Contact: Katelyn Rokenbach 203-663-3202 katelyn.rokenbach@romtech.com
Contact: Janel Shelton 203-663-3202 janel.shelton@romtech.com

Locations
Layout table for location information
United States, Arizona
OrthoArizona Recruiting
Gilbert, Arizona, United States, 85234
Contact: Dameon Hahn       dameon.hahn@romtech.com   
Contact: David Scheck       david.scheck@romtech.com   
United States, Florida
Aventura Orthopaedics Recruiting
Aventura, Florida, United States, 33180
Contact: Kourtney Trainor       kourtney.trainor@romtech.com   
Contact: David Scheck, DPT       david.scheck@romtech.com   
Orthopaedic Associates of West Florida Recruiting
Clearwater, Florida, United States, 33756
Contact: Michelle MacMillian       michelle.macmillan@romtech.com   
United States, Idaho
Institute of Orthopedic Research and Innovation Recruiting
Coeur d'Alene, Idaho, United States, 83814
Contact: Research         
United States, Tennessee
OrthoSouth Recruiting
Memphis, Tennessee, United States, 38119
Contact: Shane Tripod       shane.tripod@romtech.com   
Sponsors and Collaborators
ROM Technologies, INC
Investigators
Layout table for investigator information
Study Director: Ryan Nunley, MD ROM Tech
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: ROM Technologies, INC
ClinicalTrials.gov Identifier: NCT04497129    
Other Study ID Numbers: ROMTECH-0002
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by ROM Technologies, INC:
ROMTech
PortableConnect
Osteoarthritis
Remote monitoring
 Home Health Physical Therapy
Outpatient Physical Therapy
Rehabilitation
Physical Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Osteoarthritis
Osteoarthritis, Knee
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations