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Completed

NCT Number: NCT04497129

ROMTECH PortableConnect Rehabilitation Device Usage 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.

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Key information

Conditions

Knee Osteoarthritis Arthralgia Arthritis Joint Diseases Joint Pain Knee Arthritis Knee Disease Knee Pain Chronic Musculoskeletal Diseases Neurologic Manifestations Osteo Arthritis Knee Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OrthoArizona, Gilbert, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ROM Technologies, INC

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2020
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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