Phase
Condition
Chronic Pain
Arthritis And Arthritic Pain (Pediatric)
Rheumatoid Arthritis
Treatment
ROMTech PortableConnect
Traditional Rehabilitation and CPM Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female ≥18 years of age at screening visit.
Documentation of a definitive diagnosis of osteoarthritis of the knee requiringtotal knee arthroplasty.
Scheduled or willing to schedule TKA procedure within the timelines consistent withthe study enrollment period. This includes up to a 28-day screening window prior tothe scheduled surgery.
Willing to consent to outpatient, home-based physical therapy, CPM, or the ROMTechprotocol
Able to provide written informed consent.
Willing and able to participate in and complete all study assessments,questionnaires, and procedure
Exclusion
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 wouldcompromise the safety of the subject or the quality of the data.
History of musculoskeletal or neurological disorders that limit physical functionincluding but not limited to severe spine OA, contralateral leg issues limitingmobility, and other disorders as identified by the investigator
Planned additional knee joint surgery within 3 months of the primary scheduled TKA
Study Design
Study Description
Connect with a study center
OrthoArizona
Gilbert, Arizona 85234
United StatesSite Not Available
Aventura Orthopaedics
Aventura, Florida 33180
United StatesSite Not Available
Orthopaedic Associates of West Florida
Clearwater, Florida 33756
United StatesSite Not Available
Institute of Orthopedic Research and Innovation
Coeur d'Alene, Idaho 83814
United StatesSite Not Available
OrthoSouth
Memphis, Tennessee 38119
United StatesSite Not Available

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