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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: Completed NA study, sponsored by Columbia University.
NCT03628378 is a NA study that has completed, run by Columbia University. The registered enrollment target is 130 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
SF-12 is a patient-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is composed of a mental component score and a physical component score. The score range for each component is 0 to 100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Interventions
- DEVICE Verasense
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2017-12-20 |
| Est. Completion | 2022-06-22 |
| Phase | NA |
What the finished NCT03628378 record still lists
NCT03628378 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Verasense is the first listed.
NCT03628378 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03628378's enrollment target sits among peer trials
130 733rd of 2000 higher than 1,257 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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