ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)
CompletedNot applicableNCT04497129
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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)
- Conditions
- Interventions
- Device: ROMTech PortableConnect
- Device: Traditional Rehabilitation and CPM Device
- Sponsor
- ROM Technologies, INC
- Start date
- 2020-08-17
- Primary completion
- 2021-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04497129