Complex fixation systems

UNiD™ adaptive spine intelligence

Complex fixation systems

UNiD™ adaptive spine intelligence

UNiD™ combines adaptive spine intelligence (ASI) and predictive modelling to create patient-specific rods to correct abnormal curvature of the spine.

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Indications, Safety, and Warnings

Description

Make spine surgery predictable.

The UNiD™ ASI spinal system revolutionizes the standard of care for personalized spine surgery. Using data science and AI, spine surgeons can provide predictable and reproducible outcomes for patients with spinal deformity.

Features

Workflow

Data, meet spine surgery.

Powered by the aggregation of data from thousands of spinal procedures, the “plan, execute, analyze” process creates an iterative virtuous cycle that improves each procedure. With the UNiD™ ASI system, you’re choosing the confidence of data and the convenience of patient-specific alignment for your OR. 

Spinal deformity procedures: Plan. Execute. Analyze.

See an image of a surgeon viewing UNiD™ hub analytics on computer screen.


UNiD™ ASI leverages the aggregation of all UNiD™ procedures via a proprietary seven-step process that creates an iterative virtuous cycle.

Iterative virtuous cycle

  1. Imaging analysis
  2. Case simulation
  3. Patient-specific implants
  4. Case support
  5. Data collection
  6. Machine learning
  7. Predictive modelling
     

Clinical evidence

UNiD™ ASI rods are associated with lower incidence of rod fracture.

Evaluation of postoperative data indicates a reduction in the rod fracture rate.

In adult deformity cases (greater than five levels) at least one year after surgery, UNiD™ rods had a fracture rate of 10 out of 453 patients (2.2%). In a subset of International Spine Study Group (ISSG) data with the same parameters, 18 out of 200 (9%) of adult deformity patients experienced rod fractures.1,2

When patients from the same two studies underwent a pedicle subtraction osteotomy (PSO) in the procedure, the rate is reduced by 79%, an improvement over the 22% rod fracture rate associated with procedures involving a PSO.1,2

Rod fracture rates in adult deformity cases


9%

18 out of 200 patients
Historic ISGG data
 

2.2%

10 out of 453 patients
UNiD™ patient-specific
rod data
 

Rod fractures rate in cases involving a PSO


22%

11 out of 50 patients
Historic ISGG data
 

4.7%

6 out of 127 patients
UNiD™ patient-specific
rod data
 

Sagittal alignment is the most dominant radiographic predictor of patient outcomes.3,4

Achieving harmonious alignment of key spinopelvic parameters, such as the sagittal vertical axis (SVA), pelvic incidence/lumbar lordosis mismatch (PI-LL), and pelvic tilt (PT), is a key goal of spinal deformity surgery.5 

 Patients possessing postoperative spinopelvic parameters within normative ranges exhibit improved patient outcomes scores.2,3

Patient-specific alignment makes a difference. 
These radiographs show sagittal alignment before and after UNiD™ ASI surgery.

Rod-bending with templates yields better accuracy.

In a study by Sardi et al., ten experienced surgeons were asked to contour rods using a French bender to 40, 60, and 80 degrees.2

 Without a template, surgeons overbent by a mean of 17.5 to 20.2 degrees for each desired angle, but with a template, they came within an average of two degrees of their target angle. 

Average distance from target angle
Graph depicting that without a template, surgeons overbent by a mean of 17.5 to 20.2 degrees for each desired angle, but with a template, they came within an average of two degrees of their target angle.

Resources

This product may be protected by U.S. patents.

  1. Fiere V, Fuentes S, Burger E, Raabe T, Passias P, et al. Patient-specific rods show a reduction in rod breakage incidence. Medicrea whitepaper. October 2017.
  2. Smith JS, Shaffrey CI, Klineberg E, et al. Prospective multicenter assessment of risk factors for rod fracture following surgery for adult spinal deformity. J Neurosurg Spine. 2014;21(6):994–1003. doi:10.3171/2014.9.SPINE131176.
  3. Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine (Phila Pa 1976). 2005;30(18):2024–2029. doi:10.1097/01.brs.0000179086.30449.96.
  4. Glassman SD, Berven S, Bridwell K, Horton W, Dimar JR. Correlation of radiographic parameters and clinical symptoms in adult scoliosis. Spine (Phila Pa 1976). 2005;30(6):682–688. doi:10.1097/01.brs.0000155425.04536.f7.
  5. Jang JS, Lee SH, Min JH, Kim SK, Han KM, Maen DH. Surgical treatment of failed back surgery syndrome due to sagittal imbalance. Spine (Phila Pa 1976). 2007;32(26):30813087. doi:10.1097/BRS.0b013e31815cde71.