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

Not Applicable

• Conditions: Knee Disease; Knee Osteoarthritis; Knee Pain Chronic; Osteo Arthritis Knee; Osteoarthritis, Knee; Knee Arthritis; Joint Pain
• Interventions: Device: ROMTech PortableConnect; Device: Traditional Rehabilitation and CPM Device

• Registration Number: NCT04497129
• Lead Sponsor: ROM Technologies, INC

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.

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-04
• Study Start: 2020-08-17
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-22
• Last Update Posted: 2021-05-25
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROMTech PortableConnect	ROMTech PortableConnect	Rehabilitation Using the ROMTech PortableConnect Device
Traditional Rehabilitation & Continuous Passive Motion Device	Traditional Rehabilitation and CPM Device	Combination of OPPT and HHPT in conjunction with CPM device usage

Primary Outcome Measures

Name	Time	Method
Range of Motion	Week 9 (Follow-up)	Knee Flexion and Extension

Secondary Outcome Measures

Name	Time	Method
Timed up and go (TUG) performance	Week 9 (Follow-UP)	Assessment performed by study team
Knee swelling	Week 9 (Follow-up)	measured using a tape measure to obtain the circumference of the knee
Ambulation using the 6 Minute Walk Test (6MWT)	Week 9 (Follow-up)	Assessment performed by study team
Knee pain as measured on a 10-point pain scale	Week 9 (Follow-up)	Patient reported outcome
Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)	Week 9 (Follow-up)	Patient reported outcome
Days to return to activities of daily living	Week 9 (Follow-up)	Obtained via patient interview
Oxford Knee Score (OKS)	Week 9 (Follow-up)	Patient reported outcome
Days to ambulate without assistive devices and/or assistance	Week 9 (Follow-up)	Obtained via single response question
Opioid usage	Week 9 (Follow-up)	Compared to baseline opioid use by concomitant medication tracking at each visit
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Week 9 (Follow-up)	Patient reported outcome

Trial Locations

Locations (5)

Institute of Orthopedic Research and Innovation; 🇺🇸 Coeur d'Alene, Idaho, United States

OrthoSouth; 🇺🇸 Memphis, Tennessee, United States

OrthoArizona; 🇺🇸 Gilbert, Arizona, United States

Aventura Orthopaedics; 🇺🇸 Aventura, Florida, United States

Orthopaedic Associates of West Florida; 🇺🇸 Clearwater, Florida, United States