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

July 21, 2025 updated by: ROM Technologies, INC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • OrthoArizona
    • Florida
      • Aventura, Florida, United States, 33180
        • Aventura Orthopaedics
      • Clearwater, Florida, United States, 33756
        • Orthopaedic Associates of West Florida
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Institute of Orthopedic Research and Innovation
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • OrthoSouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: Screening
Knee Flexion and Extension
Screening
Range of Motion
Time Frame: Baseline
Knee Flexion and Extension
Baseline
Range of Motion
Time Frame: Week 1
Knee Flexion and Extension
Week 1
Range of Motion
Time Frame: Week 2
Knee Flexion and Extension
Week 2
Range of Motion
Time Frame: Week 3
Knee Flexion and Extension
Week 3
Range of Motion
Time Frame: Week 4
Knee Flexion and Extension
Week 4
Range of Motion
Time Frame: Week 5
Knee Flexion and Extension
Week 5
Range of Motion
Time Frame: Week 6
Knee Flexion and Extension
Week 6
Range of Motion
Time Frame: Week 7 (End of Treatment)
Knee Flexion and Extension
Week 7 (End of Treatment)
Range of Motion
Time Frame: Week 9 (Follow-up)
Knee Flexion and Extension
Week 9 (Follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed up and go (TUG) performance
Time Frame: Screening
Assessment performed by study team
Screening
Timed up and go (TUG) performance
Time Frame: Week 4
Assessment performed by study team
Week 4
Timed up and go (TUG) performance
Time Frame: Week 7 (End of Treatment)
Assessment performed by study team
Week 7 (End of Treatment)
Timed up and go (TUG) performance
Time Frame: Week 9 (Follow-UP)
Assessment performed by study team
Week 9 (Follow-UP)
Knee pain as measured on a 10-point pain scale
Time Frame: Screening
Patient reported outcome
Screening
Knee pain as measured on a 10-point pain scale
Time Frame: Baseline
Patient reported outcome
Baseline
Knee pain as measured on a 10-point pain scale
Time Frame: Week 1
Patient reported outcome
Week 1
Knee pain as measured on a 10-point pain scale
Time Frame: Week 2
Patient reported outcome
Week 2
Knee pain as measured on a 10-point pain scale
Time Frame: Week 3
Patient reported outcome
Week 3
Knee pain as measured on a 10-point pain scale
Time Frame: Week 4
Patient reported outcome
Week 4
Knee pain as measured on a 10-point pain scale
Time Frame: Week 5
Patient reported outcome
Week 5
Knee pain as measured on a 10-point pain scale
Time Frame: Week 6
Patient reported outcome
Week 6
Knee pain as measured on a 10-point pain scale
Time Frame: Week 7 (End of Treatment)
Patient reported outcome
Week 7 (End of Treatment)
Knee pain as measured on a 10-point pain scale
Time Frame: Week 9 (Follow-up)
Patient reported outcome
Week 9 (Follow-up)
Knee swelling
Time Frame: Screening
measured using a tape measure to obtain the circumference of the knee
Screening
Knee swelling
Time Frame: Baseline
measured using a tape measure to obtain the circumference of the knee
Baseline
Knee swelling
Time Frame: Week 1
measured using a tape measure to obtain the circumference of the knee
Week 1
Knee swelling
Time Frame: Week 2
measured using a tape measure to obtain the circumference of the knee
Week 2
Knee swelling
Time Frame: Week 3
measured using a tape measure to obtain the circumference of the knee
Week 3
Knee swelling
Time Frame: Week 4
measured using a tape measure to obtain the circumference of the knee
Week 4
Knee swelling
Time Frame: Week 5
measured using a tape measure to obtain the circumference of the knee
Week 5
Knee swelling
Time Frame: Week 6
measured using a tape measure to obtain the circumference of the knee
Week 6
Knee swelling
Time Frame: Week 7 (End of Treatment)
measured using a tape measure to obtain the circumference of the knee
Week 7 (End of Treatment)
Knee swelling
Time Frame: Week 9 (Follow-up)
measured using a tape measure to obtain the circumference of the knee
Week 9 (Follow-up)
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Screening
Patient reported outcome
Screening
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Baseline
Patient reported outcome
Baseline
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Week 1
Patient reported outcome
Week 1
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Week 2
Patient reported outcome
Week 2
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Week 3
Patient reported outcome
Week 3
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Week 4
Patient reported outcome
Week 4
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Week 5
Patient reported outcome
Week 5
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Week 6
Patient reported outcome
Week 6
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Week 7 (End of Treatment)
Patient reported outcome
Week 7 (End of Treatment)
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Time Frame: Week 9 (Follow-up)
Patient reported outcome
Week 9 (Follow-up)
Ambulation using the 6 Minute Walk Test (6MWT)
Time Frame: Screening, Baseline
Assessment performed by study team
Screening, Baseline
Ambulation using the 6 Minute Walk Test (6MWT)
Time Frame: Baseline
Assessment performed by study team
Baseline
Ambulation using the 6 Minute Walk Test (6MWT)
Time Frame: Week 4
Assessment performed by study team
Week 4
Ambulation using the 6 Minute Walk Test (6MWT)
Time Frame: Week 7 (End of Treatment)
Assessment performed by study team
Week 7 (End of Treatment)
Ambulation using the 6 Minute Walk Test (6MWT)
Time Frame: Week 9 (Follow-up)
Assessment performed by study team
Week 9 (Follow-up)
Days to ambulate without assistive devices and/or assistance
Time Frame: Screening
Obtained via single response question
Screening
Days to ambulate without assistive devices and/or assistance
Time Frame: Baseline
Obtained via single response question
Baseline
Days to ambulate without assistive devices and/or assistance
Time Frame: Week 1
Obtained via single response question
Week 1
Days to ambulate without assistive devices and/or assistance
Time Frame: Week 2
Obtained via single response question
Week 2
Days to ambulate without assistive devices and/or assistance
Time Frame: Week 3
Obtained via single response question
Week 3
Days to ambulate without assistive devices and/or assistance
Time Frame: Week 4
Obtained via single response question
Week 4
Days to ambulate without assistive devices and/or assistance
Time Frame: Week 5
Obtained via single response question
Week 5
Days to ambulate without assistive devices and/or assistance
Time Frame: Week 6
Obtained via single response question
Week 6
Days to ambulate without assistive devices and/or assistance
Time Frame: Week 7 (End of Treatment)
Obtained via single response question
Week 7 (End of Treatment)
Days to ambulate without assistive devices and/or assistance
Time Frame: Week 9 (Follow-up)
Obtained via single response question
Week 9 (Follow-up)
Days to return to activities of daily living
Time Frame: Screening
Obtained via patient interview
Screening
Days to return to activities of daily living
Time Frame: Baseline
Obtained via patient interview
Baseline
Days to return to activities of daily living
Time Frame: Week 1
Obtained via patient interview
Week 1
Days to return to activities of daily living
Time Frame: Week 2
Obtained via patient interview
Week 2
Days to return to activities of daily living
Time Frame: Week 3
Obtained via patient interview
Week 3
Days to return to activities of daily living
Time Frame: Week 4
Obtained via patient interview
Week 4
Days to return to activities of daily living
Time Frame: Week 5
Obtained via patient interview
Week 5
Days to return to activities of daily living
Time Frame: Week 6
Obtained via patient interview
Week 6
Days to return to activities of daily living
Time Frame: Week 7 (End of Treatment)
Obtained via patient interview
Week 7 (End of Treatment)
Days to return to activities of daily living
Time Frame: Week 9 (Follow-up)
Obtained via patient interview
Week 9 (Follow-up)
Opioid usage
Time Frame: Screening
Compared to baseline opioid use by concomitant medication tracking at each visit
Screening
Opioid usage
Time Frame: Baseline
Compared to baseline opioid use by concomitant medication tracking at each visit
Baseline
Opioid usage
Time Frame: Week 1
Compared to baseline opioid use by concomitant medication tracking at each visit
Week 1
Opioid usage
Time Frame: Week 2
Compared to baseline opioid use by concomitant medication tracking at each visit
Week 2
Opioid usage
Time Frame: Week 3
Compared to baseline opioid use by concomitant medication tracking at each visit
Week 3
Opioid usage
Time Frame: Week 4
Compared to baseline opioid use by concomitant medication tracking at each visit
Week 4
Opioid usage
Time Frame: Week 5
Compared to baseline opioid use by concomitant medication tracking at each visit
Week 5
Opioid usage
Time Frame: Week 6
Compared to baseline opioid use by concomitant medication tracking at each visit
Week 6
Opioid usage
Time Frame: Week 7 (End of Treatment)
Compared to baseline opioid use by concomitant medication tracking at each visit
Week 7 (End of Treatment)
Opioid usage
Time Frame: Week 9 (Follow-up)
Compared to baseline opioid use by concomitant medication tracking at each visit
Week 9 (Follow-up)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Screening
Patient reported outcome
Screening
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline
Patient reported outcome
Baseline
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 1
Patient reported outcome
Week 1
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 2
Patient reported outcome
Week 2
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 3
Patient reported outcome
Week 3
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 4
Patient reported outcome
Week 4
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 5
Patient reported outcome
Week 5
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 6
Patient reported outcome
Week 6
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 7 (End of Treatment)
Patient reported outcome
Week 7 (End of Treatment)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 9 (Follow-up)
Patient reported outcome
Week 9 (Follow-up)
Oxford Knee Score (OKS)
Time Frame: Screening
Patient reported outcome
Screening
Oxford Knee Score (OKS)
Time Frame: Baseline
Patient reported outcome
Baseline
Oxford Knee Score (OKS)
Time Frame: Week 1
Patient reported outcome
Week 1
Oxford Knee Score (OKS)
Time Frame: Week 2
Patient reported outcome
Week 2
Oxford Knee Score (OKS)
Time Frame: Week 3
Patient reported outcome
Week 3
Oxford Knee Score (OKS)
Time Frame: Week 4
Patient reported outcome
Week 4
Oxford Knee Score (OKS)
Time Frame: Week 5
Patient reported outcome
Week 5
Oxford Knee Score (OKS)
Time Frame: Week 6
Patient reported outcome
Week 6
Oxford Knee Score (OKS)
Time Frame: Week 7 (End of Treatment)
Patient reported outcome
Week 7 (End of Treatment)
Oxford Knee Score (OKS)
Time Frame: Week 9 (Follow-up)
Patient reported outcome
Week 9 (Follow-up)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Questionnaire via 4-point scale
Time Frame: Week 1
Patient Reported Outcome
Week 1
Patient Satisfaction Questionnaire via 4-point scale
Time Frame: Week 2
Patient Reported Outcome
Week 2
Patient Satisfaction Questionnaire via 4-point scale
Time Frame: Week 3
Patient Reported Outcome
Week 3
Patient Satisfaction Questionnaire via 4-point scale
Time Frame: Week 4
Patient Reported Outcome
Week 4
Patient Satisfaction Questionnaire via 4-point scale
Time Frame: Week 5
Patient Reported Outcome
Week 5
Patient Satisfaction Questionnaire via 4-point scale
Time Frame: Week 6
Patient Reported Outcome
Week 6
Patient Satisfaction Questionnaire via 4-point scale
Time Frame: Week 7 (End of Treatment)
Patient Reported Outcome
Week 7 (End of Treatment)
Patient Satisfaction Questionnaire via 4-point scale
Time Frame: Week 9 (Follow-up)
Patient Reported Outcome
Week 9 (Follow-up)
Manipulation under anesthesia
Time Frame: Baseline
By patient questionnaires
Baseline
Manipulation under anesthesia
Time Frame: Week 1
By patient questionnaires
Week 1
Manipulation under anesthesia
Time Frame: Week 2
By patient questionnaires
Week 2
Manipulation under anesthesia
Time Frame: Week 3
By patient questionnaires
Week 3
Manipulation under anesthesia
Time Frame: Week 4
By patient questionnaires
Week 4
Manipulation under anesthesia
Time Frame: Week 5
By patient questionnaires
Week 5
Manipulation under anesthesia
Time Frame: Week 6
By patient questionnaires
Week 6
Manipulation under anesthesia
Time Frame: Week 7 (End of Treatment)
By patient questionnaires
Week 7 (End of Treatment)
Manipulation under anesthesia
Time Frame: Week 9 (Follow-up)
By patient questionnaires
Week 9 (Follow-up)
Total number of physical therapy sessions completed
Time Frame: Baseline
A sum of all physical therapy sessions outpatient and home health visits
Baseline
Total number of physical therapy sessions completed
Time Frame: Week 1
A sum of all physical therapy sessions outpatient and home health visits
Week 1
Total number of physical therapy sessions completed
Time Frame: Week 2
A sum of all physical therapy sessions outpatient and home health visits
Week 2
Total number of physical therapy sessions completed
Time Frame: Week 3
A sum of all physical therapy sessions outpatient and home health visits
Week 3
Total number of physical therapy sessions completed
Time Frame: Week 4
A sum of all physical therapy sessions outpatient and home health visits
Week 4
Total number of physical therapy sessions completed
Time Frame: Week 5
A sum of all physical therapy sessions outpatient and home health visits
Week 5
Total number of physical therapy sessions completed
Time Frame: Week 6
A sum of all physical therapy sessions outpatient and home health visits
Week 6
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
Week 7 (End of Treatment)
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
Week 9 (Follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ROM Technologies, INC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ryan Nunley, MD, ROM Tech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ROMTECH-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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