Status:
COMPLETED
ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)
Lead Sponsor:
ROM Technologies, INC
Conditions:
Knee Osteoarthritis
Knee Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04497129
Start Date
August 17 2020
End Date
December 31 2021
Last Update
July 22 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
OrthoArizona
Gilbert, Arizona, United States, 85234
2
Aventura Orthopaedics
Aventura, Florida, United States, 33180
3
Orthopaedic Associates of West Florida
Clearwater, Florida, United States, 33756
4
Institute of Orthopedic Research and Innovation
Coeur d'Alene, Idaho, United States, 83814