Mode
Text Size
Log in / Sign up
N/A N=100 Randomized Triple-blind Treatment

Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty

Osteoarthritis, Knee

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Postoperative Tibial Component Alignment — 68.1; 95.7 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Digital hand-held surgical navigation system (Device); Conventional tibial extramedullary alignment system (Device)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Hospital for Special Surgery, New York
Primary completion
Mar 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Postoperative Tibial Component Alignment
68.1; 95.7
SECONDARY
Time Required to Utilize System
289.92; 70.58

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01797731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search