Knee OsteoarthritisNCT04497129
ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)
A study testing ROMTech PortableConnect and Traditional Rehabilitation and CPM Device in people with Knee Osteoarthritis and Knee Arthritis, run by ROM Technologies, INC at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic
- What is being tested?
- ROMTech PortableConnect and Traditional Rehabilitation and CPM Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Aug 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Aventura Orthopaedics
Aventura, Florida, 33180
Orthopaedic Associates of West Florida
Clearwater, Florida, 33756
Institute of Orthopedic Research and Innovation
Coeur d'Alene, Idaho, 83814
OrthoArizona
Gilbert, Arizona, 85234
OrthoSouth
Memphis, Tennessee, 38119
About this study
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)
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic, Knee Disease, Joint Pain, Osteo Arthritis Knee
- Being tested
- ROMTech PortableConnect, Traditional Rehabilitation and CPM Device
- Keywords
- ROMTech, PortableConnect, Osteoarthritis, Remote monitoring, Home Health Physical Therapy, Outpatient Physical Therapy, Rehabilitation, Physical Therapy
- Medical subject headings
- Osteoarthritis, Knee, Arthralgia, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ROMTech PortableConnect | Experimental | Rehabilitation Using the ROMTech PortableConnect Device Receives: Device: ROMTech PortableConnect |
| Traditional Rehabilitation & Continuous Passive Motion Device | Active comparator | Combination of OPPT and HHPT in conjunction with CPM device usage Receives: Device: Traditional Rehabilitation and CPM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Knee Flexion and Extension
Measured: Screening
Range of Motion
Knee Flexion and Extension
Measured: Baseline
Range of Motion
Knee Flexion and Extension
Measured: Week 1
Range of Motion
Knee Flexion and Extension
Measured: Week 2
Range of Motion
Knee Flexion and Extension
Measured: Week 3
Range of Motion
Knee Flexion and Extension
Measured: Week 4
Range of Motion
Knee Flexion and Extension
Measured: Week 5
Range of Motion
Knee Flexion and Extension
Measured: Week 6
Range of Motion
Knee Flexion and Extension
Measured: Week 7 (End of Treatment)
Range of Motion
Knee Flexion and Extension
Measured: Week 9 (Follow-up)
Secondary outcomes (89)
Timed up and go (TUG) performance
Assessment performed by study team
Measured: Screening
Timed up and go (TUG) performance
Assessment performed by study team
Measured: Week 4
Timed up and go (TUG) performance
Assessment performed by study team
Measured: Week 7 (End of Treatment)
Timed up and go (TUG) performance
Assessment performed by study team
Measured: Week 9 (Follow-UP)
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Screening
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Baseline
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Week 1
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Week 2
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Week 3
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Week 4
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Week 5
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Week 6
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Week 7 (End of Treatment)
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Measured: Week 9 (Follow-up)
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Screening
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Baseline
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Week 1
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Week 2
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Week 3
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Week 4
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Week 5
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Week 6
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Week 7 (End of Treatment)
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Measured: Week 9 (Follow-up)
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Screening
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Baseline
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Week 1
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Week 2
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Week 3
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Week 4
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Week 5
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Week 6
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Week 7 (End of Treatment)
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Measured: Week 9 (Follow-up)
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Measured: Screening, Baseline
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Measured: Baseline
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Measured: Week 4
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Measured: Week 7 (End of Treatment)
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Measured: Week 9 (Follow-up)
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Screening
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Baseline
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Week 1
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Week 2
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Week 3
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Week 4
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Week 5
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Week 6
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Week 7 (End of Treatment)
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Measured: Week 9 (Follow-up)
Days to return to activities of daily living
Obtained via patient interview
Measured: Screening
Days to return to activities of daily living
Obtained via patient interview
Measured: Baseline
Days to return to activities of daily living
Obtained via patient interview
Measured: Week 1
Days to return to activities of daily living
Obtained via patient interview
Measured: Week 2
Days to return to activities of daily living
Obtained via patient interview
Measured: Week 3
Days to return to activities of daily living
Obtained via patient interview
Measured: Week 4
Days to return to activities of daily living
Obtained via patient interview
Measured: Week 5
Days to return to activities of daily living
Obtained via patient interview
Measured: Week 6
Days to return to activities of daily living
Obtained via patient interview
Measured: Week 7 (End of Treatment)
Days to return to activities of daily living
Obtained via patient interview
Measured: Week 9 (Follow-up)
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Screening
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Baseline
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Week 1
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Week 2
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Week 3
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Week 4
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Week 5
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Week 6
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Week 7 (End of Treatment)
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Measured: Week 9 (Follow-up)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Screening
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Baseline
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Week 1
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Week 2
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Week 3
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Week 4
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Week 5
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Week 6
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Week 7 (End of Treatment)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Measured: Week 9 (Follow-up)
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Screening
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Baseline
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Week 1
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Week 2
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Week 3
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Week 4
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Week 5
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Week 6
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Week 7 (End of Treatment)
Oxford Knee Score (OKS)
Patient reported outcome
Measured: Week 9 (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start17 Aug 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- ROM Technologies, INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Nunley, MD, Study director, ROM Tech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497129
- Sponsor's protocol ID
- ROMTECH-0002
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2020
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04497129
- Acronym / sponsor ID
- ROMTECH-0002
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic, Knee Disease, Joint Pain, Osteo Arthritis Knee
- Keywords
- ROMTech, PortableConnect, Osteoarthritis, Remote monitoring, Home Health Physical Therapy, Outpatient Physical Therapy, Rehabilitation, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- ROM Technologies, INCIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROMTech PortableConnect | Experimental | Device: ROMTech PortableConnectRehabilitation Using the ROMTech PortableConnect Device |
| Traditional Rehabilitation & Continuous Passive Motion Device | Active comparator | Device: Traditional Rehabilitation and CPM DeviceCombination of OPPT and HHPT in conjunction with CPM device usage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROMTech PortableConnectROMTech 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. | Device | ROMTech PortableConnect |
| Traditional Rehabilitation and CPM DeviceContinuous 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. | Device | Traditional Rehabilitation & Continuous Passive Motion Device |
Primary outcome
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
89 secondary outcomes
Timed up and go (TUG) performance
Time frame: Screening
Timed up and go (TUG) performance
Time frame: Week 4
Timed up and go (TUG) performance
Time frame: Week 7 (End of Treatment)
Timed up and go (TUG) performance
Time frame: Week 9 (Follow-UP)
Knee pain as measured on a 10-point pain scale
Time frame: Screening
Knee pain as measured on a 10-point pain scale
Time frame: Baseline
Knee pain as measured on a 10-point pain scale
Time frame: Week 1
Knee pain as measured on a 10-point pain scale
Time frame: Week 2
Knee pain as measured on a 10-point pain scale
Time frame: Week 3
Knee pain as measured on a 10-point pain scale
Time frame: Week 4
Knee pain as measured on a 10-point pain scale
Time frame: Week 5
Knee pain as measured on a 10-point pain scale
Time frame: Week 6
Knee pain as measured on a 10-point pain scale
Time frame: Week 7 (End of Treatment)
Knee pain as measured on a 10-point pain scale
Time frame: Week 9 (Follow-up)
Knee swelling
Time frame: Screening
Knee swelling
Time frame: Baseline
Knee swelling
Time frame: Week 1
Knee swelling
Time frame: Week 2
Knee swelling
Time frame: Week 3
Knee swelling
Time frame: Week 4
Knee swelling
Time frame: Week 5
Knee swelling
Time frame: Week 6
Knee swelling
Time frame: Week 7 (End of Treatment)
Knee swelling
Time frame: Week 9 (Follow-up)
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Screening
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Baseline
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Week 1
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Week 2
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Week 3
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Week 4
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Week 5
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Week 6
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Week 7 (End of Treatment)
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time frame: Week 9 (Follow-up)
Ambulation using the 6 Minute Walk Test (6MWT)
Time frame: Screening, Baseline
Ambulation using the 6 Minute Walk Test (6MWT)
Time frame: Baseline
Ambulation using the 6 Minute Walk Test (6MWT)
Time frame: Week 4
Ambulation using the 6 Minute Walk Test (6MWT)
Time frame: Week 7 (End of Treatment)
Ambulation using the 6 Minute Walk Test (6MWT)
Time frame: Week 9 (Follow-up)
Days to ambulate without assistive devices and/or assistance
Time frame: Screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Nunley, MD study director
ROM Tech
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROMTech PortableConnect and Traditional Rehabilitation and CPM Device in people with Knee Osteoarthritis and Knee Arthritis, run by ROM Technologies, INC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: Screening). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.