Alert Indications, Safety, and Warnings

UNID™ Adaptive Spine Intelligence (ASI) UNiD™ ASI makes spine surgery predictable and repeatable using artificial intelligence — backed by data science.

We’re revolutionize the standard of care for personalized spine surgery using data science and AI so all spine surgeons can provide predictable and reproducible patient outcomes.

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Computer and phone depicting UNiD software.
Alert Indications, Safety, and Warnings

Overview

DATA, MEET SPINE SURGERY.

Powered by data aggregation of thousands of spinal procedures, the plan, execute, analyze process creates an iterative virtuous cycle that improves with each procedure. Choose the confidence of data and the convenience of custom alignment to your OR.

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PRODUCT DETAILS

Iterative Virtual Cycle

Through the power of data collection and machine learning, a unique capability is created, allowing for a continuous cycle of improvement.

Infographic depicting UNiD's continuous cycle of improvement.
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PLAN – PRE-OP PLANNING SERVICES

EXECUTE – INTRA-OP SERVICES

ANALYZE – POST-OP SERVICES

CLINICAL EVIDENCE

EXPLORE THE DATA
SEE THE RESULTS
SEE THE DIFFERENCE
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Clinical Benefits of Sagittal Alignment

Sagittal alignment is the most dominant radiographic predictor of patient outcomes.1, 2

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.1, 2

Patients possessing postoperative spinopelvic parameters within normative ranges exhibit improved patient outcomes scores.1, 2

One of the risks of not achieving optimal alignment is revision spinal surgery.3

Clinical Transition to Patient-Specific Planning and Alignment

Xray images depicting sagittal alignment.

Key Clinical Issues UNiD™ Clinical Results

62% of patients remained sagittally malaligned after surgery.4 Sagittal re-alignment and clinical outcomes are directly linked.1
  • SVA IMPROVED
    81% achieved normative SVA values
  • Significant improvement for all key parameters postoperatively5

10x greater risk of developing adjacent segment disease when postoperative ∆PI-LL ≥10° for 1 to 3 level degenerative constructs.6
  • PI-LL < 10 Achieved in all cases
  • All patients had postoperative PI-LL of less than 10°5

Better Alignment in Degen Patients

Kuris et al compared a series of 50 degenerative UNiD™ rod  patients to 578 patients from Leveque et al on the percentage of patients whose alignment improved, worsened, or stayed the same.7

Chart depicting better alignment in degen patients.

Sagittal Alignment In Ais Patients

In Solla et al, 17 hypokyphotic (<20 degrees) and 20 normal kyphosis AIS patients were treated with UNiD™ rods:8

  • Mean TK increased by 21 degrees in the hypokyphotic group and 8 degrees in the normal group
  • Zero cases of proximal junctional kyphosis (PJK) at one-year follow-up
  • Concave rod angle was correlated with postoperative TK

Parameters Overall cohort n = 37 H group n = 17 N group n = 20 p value (H vs. N)

Overall kyphosis before surgery

20 (1 to 46)

11 (1 to 19)

30 (20 to 46)

<0.0001

Planned overall kyphosis

37 (27 to 44)

37 (28 to 44)

37 (27 to 43)

0.51

Overall kyphosis at last follow-up

35 (25 to 56)

32 (25 to 39)

38 (27 to 56)

0.001

p value (overall kyphosis before surgery vs. at last follow-up)

<0.001

<0.0001

0.002

Radius Of Curvature Less Is More (Lordosis)

In a study of 60 UNiD™ rod patients, Branche et al analyzed how the radius of curvature of patient-specific rods differed between patients and at different levels.9

The rods were highly personalized, with standard deviations of 40-53% from the average curves.

For constructs above (cranial) and below (caudal) L4/L5, the rods had two distinct curves to account for greater lordosis below L4/L5.

Infographic depicting how the radius of curvature differ between patients..

 

1 ROC

2 ROC

Portion of rod

N/A

Cranial
(UIV-L4/L5

Caudal
(L4/L5-LIV)

Average curvature, mm

59

105

68

Standard deviation

23.7

55.9

28.5
Abbreviations:

LIV – lower instrumented vertebra    
N/A – not available    
ROC – radii of curvature    
UIV – upper instrumented vertebra

MACHINE LEARNING PREDICTION OF THORACIC KYPHOSIS

Prediction of Thoracic Kyphosis and Pelvic Tilt

Lee et al analyzed 20 adult deformity cases, instrumented from T10 or T11 to the pelvis, to determine the ability of UNiD™ Adaptive Spine Intelligence to predict postoperative pelvic tilt and thoracic kyphosis in un-instrumented regions of the spine.10

Postoperative Predicted p

TK (T4-T12), deg

38.3 (9.5)

37.6 (10.2)

.847

Uninstrumented TK, deg

29.8 (9.6)

33.9 (9.8)

.188

Pelvic tilt, deg

22.7 (8.7)

23.4 (7.1)

.754

These findings suggest that surgeons could use this technology to consider the risk of proximal junctional kyphosis in adult deformity patients.

UN-INSTRUMENTED THORACIC KYPHOSIS, INCLUDING OUTLIERS (>6 DEGREES)

Chart depicting findings which suggest surgeons coud use technology to consider the risk of proximal junctional kyphosis.

PELVIC TILT, INCLUDING OUTLIERS (>4 DEGREES)

Chart depicting findings which suggest surgeons coud use technology to consider the risk of proximal junctional kyphosis.

ROD BENDING WITH TEMPLATES YIELDS BETTER ACCURACY

In Sardi et al, ten experienced surgeons were asked to contour rods using a French Bender to 40, 60, and 80 degrees.11

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 DIFFERENCE FROM TARGET ANGLE

Chart depicting rod bending with templates yields better accuracy.

UNiD™ RODS ASSOCIATED WITH LOWER INCIDENCE OF ROD FRACTURE

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

In adult deformity cases (> 5 levels) at least one year after surgery, UNiD Rods had a fracture rate of 10/453 patients, or 2.2%. In a subset of International Spine Study Group (ISSG) data with the same parameters, 18/200 (9.0%) of adult deformity patients experienced rod fractures.12, 13

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 22.0% rod fracture rate associated with procedures involving a PSO.12, 13

ROD FRACTURES RATES IN ADULT DEFORMITY CASES

Chart depicting UNiD Rods had a fracture rate of 10/453 patients, or 2.2%.

ROD FRACTURES RATE IN CASES
INVOLVING A PSO

Chart depicting UNiD Rods had a fracture rate of 10/453 patients, or 2.2%.

Risks associated with these spinal implants include loosening, disassembly, bending, and/or breakage of components. A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results.

ADDITIONAL RESOURCES

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REFERENCES

1

Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S and Schwab F, The Impact of Positive Sagittal Balance in Adult Spinal Deformity. Spine. 2005.

2

Glassman SD, Berven S, Bridwell K, Horton W, Dimar JR. Correlation of radiographic parameters and clinical symptoms in adult scoliosis. Spine. 2005 Mar 15;30(6):682-8.

3

Jang J-S, Lee S-H, Min J-H, Kim SK, Han K-M, Maen DH. Surgical treatment of failed back surgery syndrome due to sagittal imbalance. Spine (Phila. Pa. 1976). 2007.

4

Moal B, Schwab F, Ames CP, et al. Radiographic Outcomes of Adult Spinal Deformity Correction: A Critical Analysis of Variability and Failures Across Deformity Patterns. Spine Deform. 2014.

5

Cameron Barton BA, Andriy Noshchenko PhD, Vikas Patel MD, Christopher Kleck MD, Evalina Burger MD. Early Experience and Initial Outcomes with Patient Specific Spine Rods for Adult Spinal Deformity (ASD). Orthopedics. 2016; 39(2):79-86.

6

Rothenfluh DA, Mueller DA, et al. Pelvic incidence lumbar lordosis mismatch predisposes to adjacent segment disease after lumbar spinal fusion. Eur Spine J (2015) 24:1251-1258.

7

Kuris, Eren, et al. “Analysis of Radiographic Parameters Reveals Differences in Outcomes When Comparing Patient-Specific Short Rod Constructs to Conventional Rods in Lumbar Fusions for Degenerative Disease.” International Meeting on Advanced Spine Technologies. 2020.

8

Solla, Federico, et al. "Patient-specific rods for thoracic kyphosis correction in adolescent idiopathic scoliosis surgery: preliminary results." Orthopaedics & Traumatology: Surgery & Research 106.1 (2020): 159-165.

9

Branche, Katherine, et al. "Radius of Curvature in Patient-Specific Short Rod Constructs Versus Standard Pre-Bent Rods." International Journal of Spine Surgery. 2020.

10

Lee, Nathan J., et al. "Can Machine Learning Accurately Predict Postoperative Compensation for the Uninstrumented Thoracic Spine and Pelvis After Fusion From the Lower Thoracic Spine to the Sacrum?." Global Spine Journal (2020).

11

Sardi, Juan Pablo, et al. "Accuracy of Rod Contouring to Desired Angles With and Without a Template: Implications for Achieving Desired Spinal Alignment and Outcomes." Global Spine Journal (2021).

12

V. Fiere, S. Fuentes, E. Burger, T. Raabe, P. Passias, et al. Patient-Specific Rods show a reduction in rod breakage incidence. Medicrea Whitepaper. October 2017.

13

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 21:994–1003, 2014.