VISIONAIRE

Patient Matched Instrumentation

 

This information is intended for health care professionals in the United States only.

Caution: US Federal law restricts the sale of these devices to or on the order of a physician.

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VISIONAIRE Patient Matched instrumentation

Product Info

VISIONAIRE Patient Matched Instrumentation uses the patient's own MRI and full leg X-Ray to design cutting blocks specific to that patient.

The manufacture of VISIONAIRE cutting blocks was featured on the hit TV show "How It's Made."

Visit the "How It's Made" website

Product Highlights

  • Eliminate up to 22 sizing and alignment steps from your surgical procedure
  • Patient-matched cutting blocks utilize the mechanical axis for alignment
  • Multiple implant options
  • Made from medical grade Nylon-12
  • Delivered sterile packed for surgery
  • Available for use with OXINIUM, or CoCr, porous coating implants
  • Efficiency, Precision, and Success

VISIONAIRE cutting blocks can be used with:

  • JOURNEY BCS
  • LEGION PRIMARY (CR and PS) 
  • GENESIS II (CR and PS)

Efficiency

Time
Is there anything more valuable? Shorten procedures by eliminating sizing and alignment surgical steps with patient matched instrumentation. Improve productivity with reduced instrumentation, requiring less set-up and turnover time.

Size
Want the confidence of walking into the OR knowing the size of the implant that will be used? With VISIONAIRE patient matched cutting blocks, precise sizing is determined pre-operatively using both MRI and X-Ray analysis.

Image showing placement of device along A/P, Epicondylar and Posterior Condylor axis.

Position
This technology achieves accurate rotational and A-P position. All of the commonly-referred anatomical landmarks (AP axis, epicondylar axis) are analyzed pre-operatively, allowing for the proper positioning of the implant for each individual.

Precision

Orientation to the mechanical axis of the knee

Proven alignment methodology
Unlike other cutting blocks that use alternate methods of alignment, VISIONAIRE blocks are aligned to the mechanical axis of the knee, the gold standard. Without this orientation to the mechanical axis, components may not achieve optimal performance.

Research shows that malalignment can lead to early failures

  • A tibial component with more than 3.0° of varus had increased odds of failure.
  • Components placed in varus alignment have a higher rate of loosening and revision when compared with components placed in neutral alignment.
  • With VISIONAIRE Patient Matched Instrumentation, surgeons can be reassured that they are implanting components in accordance with the proven standards of total knee arthroplasty.

Success

Success is built in
VISIONAIRE Patient Matched cutting blocks are made from medical grade nylon and are delivered with the size, patient name, left or right knee and implant system clearly labeled. Sterile packed with the option to be flashed, the cutting block matches standard instrumentation for intraoperative changes

Implant choice
Some companies with this technology only allow for the use of cruciate-retaining implants or limit options to a single system. VISIONAIRE Patient Matched Instrumentation is available for Smith & Nephew JOURNEY BCS Bi-Cruciate Stabilized Knee System, GENESIS II Total Knee System and LEGION PRIMARY Total Knee System in cruciate retaining and posterior stabilized options.*
*CR implants not available for JOURNEY BCS

Surgeon Control
VISIONAIRE Patient Matched Instrumentation is intended to enhance the surgeon OR experience, not to limit the surgeon's decision-making or flexibility. Changes can be made to the preop plan prior to surgery. Intraoperative flexibility is designed into each cutting block, so standard instrumentation can be utilized in the event that bone resection modifications are needed, such as additional distal resection to accommodate for a flexion contracture.

 


References

  1. Monto RR, Garcia J, Callaghan JJ. Fatal fat embolism following total condylar knee arthroplasty. J Arthroplasty. 1990. (5):291-299.
  2. Berend ME, Ritter MA, Meding JB, Faris PM, Keating EM, Redelman R, Faris GW, Davis KE. Tibial Component Failure Mechanisms in Total Knee Arthroplasty. Clin Orthop Relat Res. 2004. (428):26-34.
  3. Novak EJ, Silverstein MD, Bozic KJ. The Cost Effectiveness of Computer-Assisted Navigation in Total Knee Arthroplasty. J Bone Joint Surg Am. 2007. (89):2389-97.

Clinical Evidence

The purpose of the current prospective, randomized study was to compare the value of a new mechanically aligned patient-matched instrument system for total knee arthroplasty (TKA) (VISIONAIRE; Smith & Nephew, Inc, Memphis, Tenn) (VISIONAIRE) to that of standard TKA surgical instrumentation (STD).

Highlights from the study

  • Mechanical Varus/Valgus Alignment - VISIONAIRE group was over 1 full degree closer to neutral mechanical alignment than Standard Instrumentation group
  • Operative Time - VISIONAIRE showed a reduction of approximately 7 minutes (5%) of Operative Time
  • Length of Hospital Stay - VISIONAIRE group had a shorter Length of Stay by over 7 hours (12%)
  • Number of Instrument Trays - Instrument trays reduced by more than 3 trays (43%)
  • Incision Length - Reduced by 15mm (10%) for VISIONAIRE group
Link: The Value of Patient-Matched Instrumentation in Total Knee Arthroplasty; The Journal of Arthroplasty, Volume 27, Issue 1 , Pages 153-155, January 2012. Noble, John W.; Moore, Chris; Liu, Ning.

Design and Technology

VISIONAIRE patient matched cutting blocks use the patient's MRI and X-Ray to determine accurate alignment cuts and implant placement for each patient. However, your input on each patient is critical. You have the ability to make adjustments as you see fit to address the patient's specific anatomy, making this process not only patient specific, but surgeon specific as well.

VISIONAIRE Knee Technology addresses:

  • Varus/Valgus Alignment
  • External Rotation
  • Flexion
  • Distal Femoral Resection
  • Proximal Tibial Resection

FAQs

With what knee systems can VISIONAIRE Patient Matched Instrument be used?
JOURNEYII, LEGION GENESIS II systems are all compatible with the VISIONAIRE system.

Can VISIONAIRE Patient Matched Instrumentation be flashed?
Yes, we have done testing that the cutting blocks can be flashed up to three times without any degradation, deformation or damage to the material or cutting slot.

How is sizing determined?
Sizing is determined on AP box dimensions. The distance between the anterior resection and the posterior resections determines the size provided by Smith & Nephew.

How is alignment established?
Alignment is established by using the full leg X-Ray to determine the mechanical axis of the femur and tibia.

How is the mechanical axis determined?
The mechanical axis of the femur is considered to be the line from the center of the femoral head to the sulcus point in the intracondylar notch. The mechanical axis of the tibia is considered to be the line from the eminence to the ankle center.

What is the difference between mechanical axis and anatomical axis?
In mechanical axis alignment, the mechanical axis of both femur and tibia are made perpendicular to the ground, unless a postop mechanical varus is specified. Smith & Nephew VISIONAIRE aligns all knees to the mechanical axis and ligament balancing will be done at the discretion of the surgeon. In anatomical/cylindrical alignment, the "pre-arthritic condition" is based on an axis established by the posterior distal centers of the femoral condyles. The mechanical axis and shaft axes of the femur and tibia are ignored with anatomical alignment. A "ligament window" is also determined, so no ligament releases are performed.

Are osteophytes included in the design of cutting blocks?
Yes, osteophytes are included in the design of the blocks for two reasons:

  1. Osteophytes create a unique patient anatomy that can actually give the blocks a better fit.
  2. Eliminates any discrepancies between the VISIONAIRE team and the surgeon.

What patients are candidates for VISIONAIRE instrumentation?
Any patient that is a candidate for a primary TKA with GENESIS II, LEGION PRIMARY or JOURNEY BCS. All patients must fall within the MRI safeguards as well. This will be determined by each MRI facility's safety standards.

Contact your local Sales representative for more information, or call Customer Service at: 1-800-238-7538.

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