Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty
Completed · Not applicable
Conditions studied: Osteoarthritis, Knee
In brief
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.
Key facts
- Study ID
- NCT01797731
- Run by
- Hospital for Special Surgery, New York
- People needed
- 100
- Starts
- 2010-12-01
- Expected to finish
- 2013-09-16
- Last updated by the study team
- 2017-07-11
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- a history of osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis
- patients who have been indicated for a primary, posterior-stabilized, total knee arthroplasty
- patients have had a preoperative standing anteroposterior hip-to-ankle radiograph and standing lateral knee-to-ankle radiographs
You may not qualify if…
- patients with proximal tibial defects requiring either a metal or allograft augment
- inadequate radiographic studies as required by the study protocol
- if they do not receive a total knee arthroplasty, or receive a unicondylar arthroplasty
Where it is running
- Hospital for Special Surgery — New York, New York, United States
Full record on ClinicalTrials.gov
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