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

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. |
- Range of Motion [ Time Frame: Screening ]Knee Flexion and Extension
- Range of Motion [ Time Frame: Baseline ]Knee Flexion and Extension
- Range of Motion [ Time Frame: Week 1 ]Knee Flexion and Extension
- Range of Motion [ Time Frame: Week 2 ]Knee Flexion and Extension
- Range of Motion [ Time Frame: Week 3 ]Knee Flexion and Extension
- Range of Motion [ Time Frame: Week 4 ]Knee Flexion and Extension
- Range of Motion [ Time Frame: Week 5 ]Knee Flexion and Extension
- Range of Motion [ Time Frame: Week 6 ]Knee Flexion and Extension
- Range of Motion [ Time Frame: Week 7 (End of Treatment) ]Knee Flexion and Extension
- Range of Motion [ Time Frame: Week 9 (Follow-up) ]Knee Flexion and Extension
- Timed up and go (TUG) performance [ Time Frame: Screening ]Assessment performed by study team
- Timed up and go (TUG) performance [ Time Frame: Week 4 ]Assessment performed by study team
- Timed up and go (TUG) performance [ Time Frame: Week 7 (End of Treatment) ]Assessment performed by study team
- Timed up and go (TUG) performance [ Time Frame: Week 9 (Follow-UP) ]Assessment performed by study team
- Knee pain as measured on a 10-point pain scale [ Time Frame: Screening ]Patient reported outcome
- Knee pain as measured on a 10-point pain scale [ Time Frame: Baseline ]Patient reported outcome
- Knee pain as measured on a 10-point pain scale [ Time Frame: Week 1 ]Patient reported outcome
- Knee pain as measured on a 10-point pain scale [ Time Frame: Week 2 ]Patient reported outcome
- Knee pain as measured on a 10-point pain scale [ Time Frame: Week 3 ]Patient reported outcome
- Knee pain as measured on a 10-point pain scale [ Time Frame: Week 4 ]Patient reported outcome
- Knee pain as measured on a 10-point pain scale [ Time Frame: Week 5 ]Patient reported outcome
- Knee pain as measured on a 10-point pain scale [ Time Frame: Week 6 ]Patient reported outcome
- Knee pain as measured on a 10-point pain scale [ Time Frame: Week 7 (End of Treatment) ]Patient reported outcome
- Knee pain as measured on a 10-point pain scale [ Time Frame: Week 9 (Follow-up) ]Patient reported outcome
- Knee swelling [ Time Frame: Screening ]measured using a tape measure to obtain the circumference of the knee
- Knee swelling [ Time Frame: Baseline ]measured using a tape measure to obtain the circumference of the knee
- Knee swelling [ Time Frame: Week 1 ]measured using a tape measure to obtain the circumference of the knee
- Knee swelling [ Time Frame: Week 2 ]measured using a tape measure to obtain the circumference of the knee
- Knee swelling [ Time Frame: Week 3 ]measured using a tape measure to obtain the circumference of the knee
- Knee swelling [ Time Frame: Week 4 ]measured using a tape measure to obtain the circumference of the knee
- Knee swelling [ Time Frame: Week 5 ]measured using a tape measure to obtain the circumference of the knee
- Knee swelling [ Time Frame: Week 6 ]measured using a tape measure to obtain the circumference of the knee
- Knee swelling [ Time Frame: Week 7 (End of Treatment) ]measured using a tape measure to obtain the circumference of the knee
- Knee swelling [ Time Frame: Week 9 (Follow-up) ]measured using a tape measure to obtain the circumference of the knee
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Screening ]Patient reported outcome
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Baseline ]Patient reported outcome
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 1 ]Patient reported outcome
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 2 ]Patient reported outcome
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 3 ]Patient reported outcome
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 4 ]Patient reported outcome
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 5 ]Patient reported outcome
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 6 ]Patient reported outcome
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 7 (End of Treatment) ]Patient reported outcome
- Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS) [ Time Frame: Week 9 (Follow-up) ]Patient reported outcome
- Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Screening, Baseline ]Assessment performed by study team
- Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Baseline ]Assessment performed by study team
- Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Week 4 ]Assessment performed by study team
- Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Week 7 (End of Treatment) ]Assessment performed by study team
- Ambulation using the 6 Minute Walk Test (6MWT) [ Time Frame: Week 9 (Follow-up) ]Assessment performed by study team
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Screening ]Obtained via single response question
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Baseline ]Obtained via single response question
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 1 ]Obtained via single response question
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 2 ]Obtained via single response question
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 3 ]Obtained via single response question
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 4 ]Obtained via single response question
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 5 ]Obtained via single response question
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 6 ]Obtained via single response question
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 7 (End of Treatment) ]Obtained via single response question
- Days to ambulate without assistive devices and/or assistance [ Time Frame: Week 9 (Follow-up) ]Obtained via single response question
- Days to return to activities of daily living [ Time Frame: Screening ]Obtained via patient interview
- Days to return to activities of daily living [ Time Frame: Baseline ]Obtained via patient interview
- Days to return to activities of daily living [ Time Frame: Week 1 ]Obtained via patient interview
- Days to return to activities of daily living [ Time Frame: Week 2 ]Obtained via patient interview
- Days to return to activities of daily living [ Time Frame: Week 3 ]Obtained via patient interview
- Days to return to activities of daily living [ Time Frame: Week 4 ]Obtained via patient interview
- Days to return to activities of daily living [ Time Frame: Week 5 ]Obtained via patient interview
- Days to return to activities of daily living [ Time Frame: Week 6 ]Obtained via patient interview
- Days to return to activities of daily living [ Time Frame: Week 7 (End of Treatment) ]Obtained via patient interview
- Days to return to activities of daily living [ Time Frame: Week 9 (Follow-up) ]Obtained via patient interview
- Opioid usage [ Time Frame: Screening ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Opioid usage [ Time Frame: Baseline ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Opioid usage [ Time Frame: Week 1 ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Opioid usage [ Time Frame: Week 2 ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Opioid usage [ Time Frame: Week 3 ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Opioid usage [ Time Frame: Week 4 ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Opioid usage [ Time Frame: Week 5 ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Opioid usage [ Time Frame: Week 6 ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Opioid usage [ Time Frame: Week 7 (End of Treatment) ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Opioid usage [ Time Frame: Week 9 (Follow-up) ]Compared to baseline opioid use by concomitant medication tracking at each visit
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Screening ]Patient reported outcome
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline ]Patient reported outcome
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 1 ]Patient reported outcome
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 2 ]Patient reported outcome
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 3 ]Patient reported outcome
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 4 ]Patient reported outcome
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 5 ]Patient reported outcome
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 6 ]Patient reported outcome
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 7 (End of Treatment) ]Patient reported outcome
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Week 9 (Follow-up) ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Screening ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Baseline ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Week 1 ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Week 2 ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Week 3 ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Week 4 ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Week 5 ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Week 6 ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Week 7 (End of Treatment) ]Patient reported outcome
- Oxford Knee Score (OKS) [ Time Frame: Week 9 (Follow-up) ]Patient reported outcome
- Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 1 ]Patient Reported Outcome
- Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 2 ]Patient Reported Outcome
- Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 3 ]Patient Reported Outcome
- Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 4 ]Patient Reported Outcome
- Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 5 ]Patient Reported Outcome
- Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 6 ]Patient Reported Outcome
- Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 7 (End of Treatment) ]Patient Reported Outcome
- Patient Satisfaction Questionnaire via 4-point scale [ Time Frame: Week 9 (Follow-up) ]Patient Reported Outcome
- Manipulation under anesthesia [ Time Frame: Baseline ]By patient questionnaires
- Manipulation under anesthesia [ Time Frame: Week 1 ]By patient questionnaires
- Manipulation under anesthesia [ Time Frame: Week 2 ]By patient questionnaires
- Manipulation under anesthesia [ Time Frame: Week 3 ]By patient questionnaires
- Manipulation under anesthesia [ Time Frame: Week 4 ]By patient questionnaires
- Manipulation under anesthesia [ Time Frame: Week 5 ]By patient questionnaires
- Manipulation under anesthesia [ Time Frame: Week 6 ]By patient questionnaires
- Manipulation under anesthesia [ Time Frame: Week 7 (End of Treatment) ]By patient questionnaires
- Manipulation under anesthesia [ Time Frame: Week 9 (Follow-up) ]By patient questionnaires
- Total number of physical therapy sessions completed [ Time Frame: Baseline ]A sum of all physical therapy sessions outpatient and home health visits
- Total number of physical therapy sessions completed [ Time Frame: Week 1 ]A sum of all physical therapy sessions outpatient and home health visits
- Total number of physical therapy sessions completed [ Time Frame: Week 2 ]A sum of all physical therapy sessions outpatient and home health visits
- Total number of physical therapy sessions completed [ Time Frame: Week 3 ]A sum of all physical therapy sessions outpatient and home health visits
- Total number of physical therapy sessions completed [ Time Frame: Week 4 ]A sum of all physical therapy sessions outpatient and home health visits
- Total number of physical therapy sessions completed [ Time Frame: Week 5 ]A sum of all physical therapy sessions outpatient and home health visits
- Total number of physical therapy sessions completed [ Time Frame: Week 6 ]A sum of all physical therapy sessions outpatient and home health visits
- 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
- 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

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Katelyn Rokenbach | 203-663-3202 | katelyn.rokenbach@romtech.com | |
Contact: Janel Shelton | 203-663-3202 | janel.shelton@romtech.com |
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 | |
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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 |
Study Director: | Ryan Nunley, MD | ROM Tech |
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 |
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 |
ROMTech PortableConnect Osteoarthritis Remote monitoring |
Home Health Physical Therapy Outpatient Physical Therapy Rehabilitation Physical Therapy |
Arthritis Osteoarthritis Osteoarthritis, Knee Arthralgia Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Pain Neurologic Manifestations |