Last updated: May 22, 2021
Sponsor: ROM Technologies, INC
Overall Status: Active - Recruiting
Phase
N/A
Condition
Joint Injuries
Arthritis And Arthritic Pain (Pediatric)
Arthritis And Arthritic Pain
Treatment
N/AClinical Study ID
NCT04497129
ROMTECH-0002
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 requiring totalknee 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
Total Participants: 300
Study Start date:
August 17, 2020
Estimated Completion Date:
March 31, 2022
Study Description
Connect with a study center
OrthoArizona
Gilbert, Arizona 85234
United StatesActive - Recruiting
Aventura Orthopaedics
Aventura, Florida 33180
United StatesActive - Recruiting
Orthopaedic Associates of West Florida
Clearwater, Florida 33756
United StatesActive - Recruiting
Institute of Orthopedic Research and Innovation
Coeur d'Alene, Idaho 83814
United StatesActive - Recruiting
OrthoSouth
Memphis, Tennessee 38119
United StatesActive - Recruiting
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