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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)
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