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

ROM Technologies, INC300 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Knee Osteoarthritis Knee Arthritis

Interventions

ROMTech PortableConnectDEVICE

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 DeviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

OrthoArizona

Gilbert, Arizona, United States

Aventura Orthopaedics

Aventura, Florida, United States

Orthopaedic Associates of West Florida

Clearwater, Florida, United States

Institute of Orthopedic Research and Innovation

Coeur d'Alene, Idaho, United States

OrthoSouth

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Range of Motion

Knee Flexion and Extension

Time frame: Screening

Range of Motion

Knee Flexion and Extension

Time frame: Baseline

Range of Motion

Knee Flexion and Extension

Time frame: Week 1

Range of Motion

Knee Flexion and Extension

Time frame: Week 2

Range of Motion

Knee Flexion and Extension

Time frame: Week 3

Range of Motion

Knee Flexion and Extension

Time frame: Week 4

Range of Motion

Knee Flexion and Extension

Time frame: Week 5

Range of Motion

Knee Flexion and Extension

Time frame: Week 6

Range of Motion

Knee Flexion and Extension

Time frame: Week 7 (End of Treatment)

Range of Motion

Knee Flexion and Extension

Time frame: Week 9 (Follow-up)

Secondary Outcomes

Timed up and go (TUG) performance

Assessment performed by study team

Time frame: Screening

Timed up and go (TUG) performance

Assessment performed by study team

Time frame: Week 4

Timed up and go (TUG) performance

Assessment performed by study team

Time frame: Week 7 (End of Treatment)

Timed up and go (TUG) performance

Assessment performed by study team

Time frame: Week 9 (Follow-UP)

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Screening

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Baseline

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Week 1

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Week 2

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Week 3

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Week 4

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Week 5

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Week 6

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Week 7 (End of Treatment)

Knee pain as measured on a 10-point pain scale

Patient reported outcome

Time frame: Week 9 (Follow-up)

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Screening

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Baseline

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Week 1

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Week 2

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Week 3

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Week 4

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Week 5

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Week 6

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Week 7 (End of Treatment)

Knee swelling

measured using a tape measure to obtain the circumference of the knee

Time frame: Week 9 (Follow-up)

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Screening

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Baseline

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Week 1

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Week 2

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Week 3

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Week 4

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Week 5

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Week 6

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Week 7 (End of Treatment)

Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)

Patient reported outcome

Time frame: Week 9 (Follow-up)

Ambulation using the 6 Minute Walk Test (6MWT)

Assessment performed by study team

Time frame: Screening, Baseline

Ambulation using the 6 Minute Walk Test (6MWT)

Assessment performed by study team

Time frame: Baseline

Ambulation using the 6 Minute Walk Test (6MWT)

Assessment performed by study team

Time frame: Week 4

Ambulation using the 6 Minute Walk Test (6MWT)

Assessment performed by study team

Time frame: Week 7 (End of Treatment)

Ambulation using the 6 Minute Walk Test (6MWT)

Assessment performed by study team

Time frame: Week 9 (Follow-up)

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Screening

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Baseline

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Week 1

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Week 2

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Week 3

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Week 4

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Week 5

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Week 6

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Week 7 (End of Treatment)

Days to ambulate without assistive devices and/or assistance

Obtained via single response question

Time frame: Week 9 (Follow-up)

Days to return to activities of daily living

Obtained via patient interview

Time frame: Screening

Days to return to activities of daily living

Obtained via patient interview

Time frame: Baseline

Days to return to activities of daily living

Obtained via patient interview

Time frame: Week 1

Days to return to activities of daily living

Obtained via patient interview

Time frame: Week 2

Days to return to activities of daily living

Obtained via patient interview

Time frame: Week 3

Days to return to activities of daily living

Obtained via patient interview

Time frame: Week 4

Days to return to activities of daily living

Obtained via patient interview

Time frame: Week 5

Days to return to activities of daily living

Obtained via patient interview

Time frame: Week 6

Days to return to activities of daily living

Obtained via patient interview

Time frame: Week 7 (End of Treatment)

Days to return to activities of daily living

Obtained via patient interview

Time frame: Week 9 (Follow-up)

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Screening

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Baseline

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Week 1

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Week 2

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Week 3

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Week 4

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Week 5

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Week 6

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Week 7 (End of Treatment)

Opioid usage

Compared to baseline opioid use by concomitant medication tracking at each visit

Time frame: Week 9 (Follow-up)

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Screening

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Baseline

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Week 1

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Week 2

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Week 3

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Week 4

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Week 5

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Week 6

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Week 7 (End of Treatment)

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcome

Time frame: Week 9 (Follow-up)

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Screening

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Baseline

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Week 1

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Week 2

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Week 3

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Week 4

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Week 5

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Week 6

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Week 7 (End of Treatment)

Oxford Knee Score (OKS)

Patient reported outcome

Time frame: Week 9 (Follow-up)