Clinical trial NCT04497129: ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: ROM Technologies, INC
Sponsor class: INDUSTRY
First posted: 2020-08-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Range of Motion
timeFrame: Screening
measure: Range of Motion
timeFrame: Baseline
measure: Range of Motion
timeFrame: Week 1
measure: Range of Motion
timeFrame: Week 2
measure: Range of Motion
timeFrame: Week 3
measure: Range of Motion
timeFrame: Week 4
measure: Range of Motion
timeFrame: Week 5
measure: Range of Motion
timeFrame: Week 6
measure: Range of Motion
timeFrame: Week 7 (End of Treatment)
measure: Range of Motion
timeFrame: Week 9 (Follow-up)
Secondary outcomes:
measure: Timed up and go (TUG) performance
timeFrame: Screening
measure: Timed up and go (TUG) performance
timeFrame: Week 4
measure: Timed up and go (TUG) performance
timeFrame: Week 7 (End of Treatment)
measure: Timed up and go (TUG) performance
timeFrame: Week 9 (Follow-UP)
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Screening
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Baseline
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Week 1
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Week 2
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Week 3
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Week 4
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Week 5
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Week 6
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Week 7 (End of Treatment)
measure: Knee pain as measured on a 10-point pain scale
timeFrame: Week 9 (Follow-up)
measure: Knee swelling
timeFrame: Screening
measure: Knee swelling
timeFrame: Baseline
measure: Knee swelling
timeFrame: Week 1
measure: Knee swelling
timeFrame: Week 2
measure: Knee swelling
timeFrame: Week 3
measure: Knee swelling
timeFrame: Week 4
measure: Knee swelling
timeFrame: Week 5
measure: Knee swelling
timeFrame: Week 6
measure: Knee swelling
timeFrame: Week 7 (End of Treatment)
measure: Knee swelling
timeFrame: Week 9 (Follow-up)
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Screening
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Baseline
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Week 1
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Week 2
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Week 3
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Week 4
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Week 5
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Week 6
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Week 7 (End of Treatment)
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
timeFrame: Week 9 (Follow-up)
measure: Ambulation using the 6 Minute Walk Test (6MWT)
timeFrame: Screening, Baseline
measure: Ambulation using the 6 Minute Walk Test (6MWT)
timeFrame: Baseline
measure: Ambulation using the 6 Minute Walk Test (6MWT)
timeFrame: Week 4
measure: Ambulation using the 6 Minute Walk Test (6MWT)
timeFrame: Week 7 (End of Treatment)
measure: Ambulation using the 6 Minute Walk Test (6MWT)
timeFrame: Week 9 (Follow-up)
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Screening
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Baseline
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Week 1
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Week 2
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Week 3
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Week 4
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Week 5
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Week 6
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Week 7 (End of Treatment)
measure: Days to ambulate without assistive devices and/or assistance
timeFrame: Week 9 (Follow-up)
measure: Days to return to activities of daily living
timeFrame: Screening
measure: Days to return to activities of daily living
timeFrame: Baseline
measure: Days to return to activities of daily living
timeFrame: Week 1
measure: Days to return to activities of daily living
timeFrame: Week 2
measure: Days to return to activities of daily living
timeFrame: Week 3
measure: Days to return to activities of daily living
timeFrame: Week 4
measure: Days to return to activities of daily living
timeFrame: Week 5
measure: Days to return to activities of daily living
timeFrame: Week 6
measure: Days to return to activities of daily living
timeFrame: Week 7 (End of Treatment)
measure: Days to return to activities of daily living
timeFrame: Week 9 (Follow-up)
measure: Opioid usage
timeFrame: Screening
measure: Opioid usage
timeFrame: Baseline
measure: Opioid usage
timeFrame: Week 1
measure: Opioid usage
timeFrame: Week 2
measure: Opioid usage
timeFrame: Week 3
measure: Opioid usage
timeFrame: Week 4
measure: Opioid usage
timeFrame: Week 5
measure: Opioid usage
timeFrame: Week 6
measure: Opioid usage
timeFrame: Week 7 (End of Treatment)
measure: Opioid usage
timeFrame: Week 9 (Follow-up)
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Screening
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 1
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 2
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 3
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 4
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 5
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 6
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 7 (End of Treatment)
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 9 (Follow-up)
measure: Oxford Knee Score (OKS)
timeFrame: Screening
measure: Oxford Knee Score (OKS)
timeFrame: Baseline
measure: Oxford Knee Score (OKS)
timeFrame: Week 1
measure: Oxford Knee Score (OKS)
timeFrame: Week 2
measure: Oxford Knee Score (OKS)
timeFrame: Week 3
measure: Oxford Knee Score (OKS)
timeFrame: Week 4
measure: Oxford Knee Score (OKS)
timeFrame: Week 5
measure: Oxford Knee Score (OKS)
timeFrame: Week 6
measure: Oxford Knee Score (OKS)
timeFrame: Week 7 (End of Treatment)
measure: Oxford Knee Score (OKS)
timeFrame: Week 9 (Follow-up)
Other outcomes:
measure: Patient Satisfaction Questionnaire via 4-point scale
timeFrame: Week 1
measure: Patient Satisfaction Questionnaire via 4-point scale
timeFrame: Week 2
measure: Patient Satisfaction Questionnaire via 4-point scale
timeFrame: Week 3
measure: Patient Satisfaction Questionnaire via 4-point scale
timeFrame: Week 4
measure: Patient Satisfaction Questionnaire via 4-point scale
timeFrame: Week 5
measure: Patient Satisfaction Questionnaire via 4-point scale
timeFrame: Week 6
measure: Patient Satisfaction Questionnaire via 4-point scale
timeFrame: Week 7 (End of Treatment)
measure: Patient Satisfaction Questionnaire via 4-point scale
timeFrame: Week 9 (Follow-up)
measure: Manipulation under anesthesia
timeFrame: Baseline
measure: Manipulation under anesthesia
timeFrame: Week 1
measure: Manipulation under anesthesia
timeFrame: Week 2
measure: Manipulation under anesthesia
timeFrame: Week 3
measure: Manipulation under anesthesia
timeFrame: Week 4
measure: Manipulation under anesthesia
timeFrame: Week 5
measure: Manipulation under anesthesia
timeFrame: Week 6
measure: Manipulation under anesthesia
timeFrame: Week 7 (End of Treatment)
measure: Manipulation under anesthesia
timeFrame: Week 9 (Follow-up)
measure: Total number of physical therapy sessions completed
timeFrame: Baseline
measure: Total number of physical therapy sessions completed
timeFrame: Week 1
measure: Total number of physical therapy sessions completed
timeFrame: Week 2
measure: Total number of physical therapy sessions completed
timeFrame: Week 3
measure: Total number of physical therapy sessions completed
timeFrame: Week 4
measure: Total number of physical therapy sessions completed
timeFrame: Week 5
measure: Total number of physical therapy sessions completed
timeFrame: Week 6
measure: Total number of physical therapy sessions completed
timeFrame: Week 7 (End of Treatment)
measure: Total number of physical therapy sessions completed
timeFrame: Week 9 (Follow-up)
Locations:
city: Gilbert
country: United States
facility: OrthoArizona
state: Arizona
city: Aventura
country: United States
facility: Aventura Orthopaedics
state: Florida
city: Clearwater
country: United States
facility: Orthopaedic Associates of West Florida
state: Florida
city: Coeur d'Alene
country: United States
facility: Institute of Orthopedic Research and Innovation
state: Idaho
city: Memphis
country: United States
facility: OrthoSouth
state: Tennessee
Study officials:
affiliation: ROM Tech
name: Ryan Nunley, MD
role: STUDY_DIRECTOR
References: