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NCT03628378 · ClinicalTrials.gov registry record · NA
Orthosensor vs Conventional Total Knee Arthroplasty
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 130
- Enrollment target
NCT03628378 is a NA study that has completed, run by Columbia University. The registered enrollment target is 130 participants.
The verdict
NCT03628378, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
Study Summary
In a randomized-controlled fashion, this investigation will evaluate the use of the Verasense technology to achieve optimal TKA balance. Patients will be randomized to either: 1) undergo manual soft tissue balancing or 2) soft tissue balancing with the Verasense. The primary outcomes of interest will include patient-reported outcomes as well knee range of motion at 3 months, 6 months, 1 year, and 2 years. Secondary outcomes of interest will include pain level as assessed by the visual analogue scale (VAS) in the acute post-operative and follow up periods, ambulation distance during inpatient physical therapy postoperatively, surgical time, tourniquet time, amount of opioid consumption, length of hospital stay, incidence of arthrofibrosis and subsequent manipulation under anesthesia. The investigators hypothesize that the use of the Verasense technology will lead to improved soft tissue balancing in TKA and ultimately result in favorable patient-reported outcomes and postoperative knee range of motion.
Interventions
- DEVICE Verasense
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2017-12-20 |
| Est. Completion | 2022-06-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03628378
The ClinicalTrials.gov registry entry for NCT03628378 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Verasense is the first listed.
NCT03628378 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03628378 about?
NCT03628378 is a clinical study titled "Orthosensor vs Conventional Total Knee Arthroplasty". In a randomized-controlled fashion, this investigation will evaluate the use of the Verasense technology to achieve optimal TKA balance. Patients will be randomized to either: 1) undergo manual soft tissue balancing or 2) soft tissue balancing with the Verasense. The primary outcomes of interest wil...
What is the current status of trial NCT03628378?
This trial is currently completed. It is a NA study. The enrollment target is 130 participants. The study started on 2017-12-20. Estimated completion is 2022-06-22.
What interventions are being tested in trial NCT03628378?
The interventions under investigation include: Verasense (DEVICE).
Who is sponsoring clinical trial NCT03628378?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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