CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
Verasensedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03628378
NCT03628378N/ACompleted

Outcomes in Free-hand Versus Sensor-guided Balancing in Total Knee Arthroplasty: a Randomized Controlled Trial

Columbia University·interventional·Posted Aug 14, 2018·Updated Sep 24, 2024

In Brief

A clinical study evaluating Verasense for Osteoarthritis, Knee. Completed, enrolled 130 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartDec 20, 2017
Primary CompletionJun 22, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.9 years ago

Interventions

Verasensedevice

Ligamentous balancing device