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

Knee Osteoarthritis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497129
• Other study ID #: ROMTECH-0002
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: March 2022

Study information

• Verified date: May 2021
• Source: ROM Technologies, INC
• Contact: Katelyn Rokenbach
• Phone: 203-663-3202
• Email: katelyn.rokenbach[@]romtech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Arthritis
• Joint Pain
• Knee Arthritis
• Knee Disease
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Aventura Orthopaedics	Aventura	Florida
United States	Orthopaedic Associates of West Florida	Clearwater	Florida
United States	Institute of Orthopedic Research and Innovation	Coeur d'Alene	Idaho
United States	OrthoArizona	Gilbert	Arizona
United States	OrthoSouth	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
ROM Technologies, INC

Country where clinical trial is conducted

United States, 

Outcome

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