ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)
Primary Purpose
Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ROMTech PortableConnect
Traditional Rehabilitation and CPM Device
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring ROMTech, PortableConnect, Osteoarthritis, Remote monitoring, Home Health Physical Therapy, Outpatient Physical Therapy, Rehabilitation, Physical Therapy
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥18 years of age at screening visit.
- Documentation of a definitive diagnosis of osteoarthritis of the knee requiring total knee arthroplasty.
- Scheduled or willing to schedule TKA procedure within the timelines consistent with the study enrollment period. This includes up to a 28-day screening window prior to the scheduled surgery.
- Willing to consent to outpatient, home-based physical therapy, CPM, or the ROMTech protocol
- Able to provide written informed consent.
- Willing and able to participate in and complete all study assessments, questionnaires, and procedure
Exclusion Criteria:
- Inability to provide informed consent.
- Inability to understand and complete study related assessments and procedures.
- Other scheduled surgical knee procedures in addition to the TKA.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
- History of musculoskeletal or neurological disorders that limit physical function including but not limited to severe spine OA, contralateral leg issues limiting mobility, and other disorders as identified by the investigator
- Planned additional knee joint surgery within 3 months of the primary scheduled TKA
Sites / Locations
- OrthoArizonaRecruiting
- Aventura OrthopaedicsRecruiting
- Orthopaedic Associates of West FloridaRecruiting
- Institute of Orthopedic Research and InnovationRecruiting
- OrthoSouthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ROMTech PortableConnect
Traditional Rehabilitation & Continuous Passive Motion Device
Arm Description
Rehabilitation Using the ROMTech PortableConnect Device
Combination of OPPT and HHPT in conjunction with CPM device usage
Outcomes
Primary Outcome Measures
Range of Motion
Knee Flexion and Extension
Range of Motion
Knee Flexion and Extension
Range of Motion
Knee Flexion and Extension
Range of Motion
Knee Flexion and Extension
Range of Motion
Knee Flexion and Extension
Range of Motion
Knee Flexion and Extension
Range of Motion
Knee Flexion and Extension
Range of Motion
Knee Flexion and Extension
Range of Motion
Knee Flexion and Extension
Range of Motion
Knee Flexion and Extension
Secondary Outcome Measures
Timed up and go (TUG) performance
Assessment performed by study team
Timed up and go (TUG) performance
Assessment performed by study team
Timed up and go (TUG) performance
Assessment performed by study team
Timed up and go (TUG) performance
Assessment performed by study team
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee pain as measured on a 10-point pain scale
Patient reported outcome
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Knee swelling
measured using a tape measure to obtain the circumference of the knee
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Patient reported outcome
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Ambulation using the 6 Minute Walk Test (6MWT)
Assessment performed by study team
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to ambulate without assistive devices and/or assistance
Obtained via single response question
Days to return to activities of daily living
Obtained via patient interview
Days to return to activities of daily living
Obtained via patient interview
Days to return to activities of daily living
Obtained via patient interview
Days to return to activities of daily living
Obtained via patient interview
Days to return to activities of daily living
Obtained via patient interview
Days to return to activities of daily living
Obtained via patient interview
Days to return to activities of daily living
Obtained via patient interview
Days to return to activities of daily living
Obtained via patient interview
Days to return to activities of daily living
Obtained via patient interview
Days to return to activities of daily living
Obtained via patient interview
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Opioid usage
Compared to baseline opioid use by concomitant medication tracking at each visit
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Oxford Knee Score (OKS)
Patient reported outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04497129
Brief Title
ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)
Official Title
Randomized Multicenter Comparative Trial Evaluating the Impact of the ROMTECH PortableConnect Rehabilitation Device on Time to Recovery and Comprehensive Rehabilitation Outcomes Post Unilateral Total Knee Arthroplasty (TKA)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ROM Technologies, INC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
ROMTech is focused on transforming the healthcare market by delivering lower extremity rehabilitation systems that are effective, efficient for patient use, cost-effective, and provide better patient outcomes while simultaneously decreasing rehabilitation and overall recovery times.
Detailed Description
The patented technology of the ROMTech PortableConnect can improve the rehabilitation protocol for lower extremities in shorter time periods. The focus of this study is to compare the effectiveness of the ROMTech PortableConncect device only rehabilitation program following total knee arthroplasty to an active comparator group of continuous passive motion with a standard of care combination HHPT and OPPT rehabilitation program. The technology used to develop the ROMTech PortableConnect device has been reported in a pilot study to tend to be highly effective in decreasing the recovery time of patients post TKA, as discussed in the findings from the pilot study with the ROMTech Pro Cycle. The expedited recovery resulting from use of the ROMTech rehabilitation technology is noted to be contributed to the ability of the ROMTech technology to achieve a more rapid range of motion in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic, Knee Disease, Joint Pain, Osteo Arthritis Knee, Osteoarthritis, Knee
Keywords
ROMTech, PortableConnect, Osteoarthritis, Remote monitoring, Home Health Physical Therapy, Outpatient Physical Therapy, Rehabilitation, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ROMTech PortableConnect
Arm Type
Experimental
Arm Description
Rehabilitation Using the ROMTech PortableConnect Device
Arm Title
Traditional Rehabilitation & Continuous Passive Motion Device
Arm Type
Active Comparator
Arm Description
Combination of OPPT and HHPT in conjunction with CPM device usage
Intervention Type
Device
Intervention Name(s)
ROMTech PortableConnect
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional Rehabilitation and CPM Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Screening
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Baseline
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Week 1
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Week 2
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Week 3
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Week 4
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Week 5
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Week 6
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Week 7 (End of Treatment)
Title
Range of Motion
Description
Knee Flexion and Extension
Time Frame
Week 9 (Follow-up)
Secondary Outcome Measure Information:
Title
Timed up and go (TUG) performance
Description
Assessment performed by study team
Time Frame
Screening
Title
Timed up and go (TUG) performance
Description
Assessment performed by study team
Time Frame
Week 4
Title
Timed up and go (TUG) performance
Description
Assessment performed by study team
Time Frame
Week 7 (End of Treatment)
Title
Timed up and go (TUG) performance
Description
Assessment performed by study team
Time Frame
Week 9 (Follow-UP)
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Screening
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Baseline
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Week 1
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Week 2
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Week 3
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Week 4
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Week 5
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Week 6
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Week 7 (End of Treatment)
Title
Knee pain as measured on a 10-point pain scale
Description
Patient reported outcome
Time Frame
Week 9 (Follow-up)
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Screening
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Baseline
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Week 1
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Week 2
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Week 3
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Week 4
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Week 5
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Week 6
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Week 7 (End of Treatment)
Title
Knee swelling
Description
measured using a tape measure to obtain the circumference of the knee
Time Frame
Week 9 (Follow-up)
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Screening
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Baseline
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Week 1
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Week 2
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Week 3
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Week 4
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Week 5
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Week 6
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Week 7 (End of Treatment)
Title
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
Description
Patient reported outcome
Time Frame
Week 9 (Follow-up)
Title
Ambulation using the 6 Minute Walk Test (6MWT)
Description
Assessment performed by study team
Time Frame
Screening, Baseline
Title
Ambulation using the 6 Minute Walk Test (6MWT)
Description
Assessment performed by study team
Time Frame
Baseline
Title
Ambulation using the 6 Minute Walk Test (6MWT)
Description
Assessment performed by study team
Time Frame
Week 4
Title
Ambulation using the 6 Minute Walk Test (6MWT)
Description
Assessment performed by study team
Time Frame
Week 7 (End of Treatment)
Title
Ambulation using the 6 Minute Walk Test (6MWT)
Description
Assessment performed by study team
Time Frame
Week 9 (Follow-up)
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Screening
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Baseline
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Week 1
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Week 2
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Week 3
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Week 4
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Week 5
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Week 6
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Week 7 (End of Treatment)
Title
Days to ambulate without assistive devices and/or assistance
Description
Obtained via single response question
Time Frame
Week 9 (Follow-up)
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Screening
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Baseline
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Week 1
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Week 2
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Week 3
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Week 4
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Week 5
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Week 6
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Week 7 (End of Treatment)
Title
Days to return to activities of daily living
Description
Obtained via patient interview
Time Frame
Week 9 (Follow-up)
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Screening
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Baseline
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Week 1
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Week 2
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Week 3
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Week 4
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Week 5
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Week 6
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Week 7 (End of Treatment)
Title
Opioid usage
Description
Compared to baseline opioid use by concomitant medication tracking at each visit
Time Frame
Week 9 (Follow-up)
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Screening
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Baseline
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Week 1
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Week 2
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Week 3
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Week 4
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Week 5
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Week 6
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Week 7 (End of Treatment)
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome
Time Frame
Week 9 (Follow-up)
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Screening
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Baseline
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Week 1
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Week 2
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Week 3
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Week 4
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Week 5
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Week 6
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Week 7 (End of Treatment)
Title
Oxford Knee Score (OKS)
Description
Patient reported outcome
Time Frame
Week 9 (Follow-up)
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction Questionnaire via 4-point scale
Description
Patient Reported Outcome
Time Frame
Week 1
Title
Patient Satisfaction Questionnaire via 4-point scale
Description
Patient Reported Outcome
Time Frame
Week 2
Title
Patient Satisfaction Questionnaire via 4-point scale
Description
Patient Reported Outcome
Time Frame
Week 3
Title
Patient Satisfaction Questionnaire via 4-point scale
Description
Patient Reported Outcome
Time Frame
Week 4
Title
Patient Satisfaction Questionnaire via 4-point scale
Description
Patient Reported Outcome
Time Frame
Week 5
Title
Patient Satisfaction Questionnaire via 4-point scale
Description
Patient Reported Outcome
Time Frame
Week 6
Title
Patient Satisfaction Questionnaire via 4-point scale
Description
Patient Reported Outcome
Time Frame
Week 7 (End of Treatment)
Title
Patient Satisfaction Questionnaire via 4-point scale
Description
Patient Reported Outcome
Time Frame
Week 9 (Follow-up)
Title
Manipulation under anesthesia
Description
By patient questionnaires
Time Frame
Baseline
Title
Manipulation under anesthesia
Description
By patient questionnaires
Time Frame
Week 1
Title
Manipulation under anesthesia
Description
By patient questionnaires
Time Frame
Week 2
Title
Manipulation under anesthesia
Description
By patient questionnaires
Time Frame
Week 3
Title
Manipulation under anesthesia
Description
By patient questionnaires
Time Frame
Week 4
Title
Manipulation under anesthesia
Description
By patient questionnaires
Time Frame
Week 5
Title
Manipulation under anesthesia
Description
By patient questionnaires
Time Frame
Week 6
Title
Manipulation under anesthesia
Description
By patient questionnaires
Time Frame
Week 7 (End of Treatment)
Title
Manipulation under anesthesia
Description
By patient questionnaires
Time Frame
Week 9 (Follow-up)
Title
Total number of physical therapy sessions completed
Description
A sum of all physical therapy sessions outpatient and home health visits
Time Frame
Baseline
Title
Total number of physical therapy sessions completed
Description
A sum of all physical therapy sessions outpatient and home health visits
Time Frame
Week 1
Title
Total number of physical therapy sessions completed
Description
A sum of all physical therapy sessions outpatient and home health visits
Time Frame
Week 2
Title
Total number of physical therapy sessions completed
Description
A sum of all physical therapy sessions outpatient and home health visits
Time Frame
Week 3
Title
Total number of physical therapy sessions completed
Description
A sum of all physical therapy sessions outpatient and home health visits
Time Frame
Week 4
Title
Total number of physical therapy sessions completed
Description
A sum of all physical therapy sessions outpatient and home health visits
Time Frame
Week 5
Title
Total number of physical therapy sessions completed
Description
A sum of all physical therapy sessions outpatient and home health visits
Time Frame
Week 6
Title
Total number of physical therapy sessions completed
Description
A sum of all physical therapy sessions outpatient and home health visits
Time Frame
Week 7 (End of Treatment)
Title
Total number of physical therapy sessions completed
Description
A sum of all physical therapy sessions outpatient and home health visits
Time Frame
Week 9 (Follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥18 years of age at screening visit.
Documentation of a definitive diagnosis of osteoarthritis of the knee requiring total knee arthroplasty.
Scheduled or willing to schedule TKA procedure within the timelines consistent with the study enrollment period. This includes up to a 28-day screening window prior to the scheduled surgery.
Willing to consent to outpatient, home-based physical therapy, CPM, or the ROMTech protocol
Able to provide written informed consent.
Willing and able to participate in and complete all study assessments, questionnaires, and procedure
Exclusion Criteria:
Inability to provide informed consent.
Inability to understand and complete study related assessments and procedures.
Other scheduled surgical knee procedures in addition to the TKA.
Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
History of musculoskeletal or neurological disorders that limit physical function including but not limited to severe spine OA, contralateral leg issues limiting mobility, and other disorders as identified by the investigator
Planned additional knee joint surgery within 3 months of the primary scheduled TKA
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katelyn Rokenbach
Phone
203-663-3202
Email
katelyn.rokenbach@romtech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Janel Shelton
Phone
203-663-3202
Email
janel.shelton@romtech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Nunley, MD
Organizational Affiliation
ROM Tech
Official's Role
Study Director
Facility Information:
Facility Name
OrthoArizona
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dameon Hahn
Email
dameon.hahn@romtech.com
First Name & Middle Initial & Last Name & Degree
David Scheck
Email
david.scheck@romtech.com
Facility Name
Aventura Orthopaedics
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kourtney Trainor
Email
kourtney.trainor@romtech.com
First Name & Middle Initial & Last Name & Degree
David Scheck, DPT
Email
david.scheck@romtech.com
Facility Name
Orthopaedic Associates of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle MacMillian
Email
michelle.macmillan@romtech.com
Facility Name
Institute of Orthopedic Research and Innovation
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research
Facility Name
OrthoSouth
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shane Tripod
Email
shane.tripod@romtech.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)
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