N/A
N=100
Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT01797731 ↗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
| Outcome | Result | p-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
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.