CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Digital hand-held surgical navigation system +1 moredevice
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/NCT01797731
NCT01797731N/ACompleted

Conventional Tibial Extramedullary Alignment System Versus a Hand-Held, Surgical Navigation System for Tibial Component Placement in Total Knee Arthroplasty: A Randomized, Controlled Trial

Hospital for Special Surgery, New York·interventional·Posted Feb 22, 2013·Updated Jul 11, 2017

In Brief

A clinical study evaluating Digital hand-held surgical navigation system and Conventional tibial extramedullary alignment system for Osteoarthritis, Knee. Completed, enrolled 100 participants across 1 site.

Detailed Summary

This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) implant components. The investigators expect that the FDA-approved hand-held surgical navigation device will increase the accuracy and precision of the tibial cut by telling the surgeon the exact position of the cutting block before the surgeon makes the cut, allowing minor adjustments to be made. The investigators expect the conventional device to take less time to use, but that this difference will decrease as the surgeon becomes more familiar with the device. The investigators expect the intraoperative measurements acquired by the KneeAlign system to strongly correlate with the radiographic alignments measured postoperatively.

Study Details

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

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2013
Enrollment StartDec 1, 2010
Primary CompletionMar 1, 2013
Study CompletionSep 16, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.4 years ago

Interventions

Digital hand-held surgical navigation systemdevice

Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty

Conventional tibial extramedullary alignment systemdevice

This is the standard of care for total knee arthroplasty.