SACROPLASTY For Sacral Insufficiency Fractures

TREATING PATHOLOGICAL FRACTURES OF THE SACRAL VERTEBRAL BODY

Sacroplasty is a minimally invasive procedure for treating pathological fractures of the sacral vertebral body or sacral ala.

Bi-Lateral Short Axis Sacroplasty

Bi-lateral Short Axis Sacroplasty

Bi-Lateral Long Axis Sacroplasty

Bi-lateral Long Axis Sacroplasty

HOW IT WORKS

The goal of sacroplasty is to relieve pain and stabilize the fracture.1,2 This procedure involves:

  • Percutaneously inserting one or more bone needles into the sacrum under Fluoroscopy and/or CT visual guidance
  • Injecting Bone Cement under imaging to stabilize the fracture

SACROPLASTY TECHNIQUE GUIDE: SHORT-AXIS TECHNIQUE - (20:25)

Labib Haddad, MD, demonstrates how to perform sacroplasty using the short-axis technique.
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SACROPLASTY TECHNIQUE GUIDE: LONG-AXIS TECHNIQUE - (15:02)

Labib Haddad, MD, demonstrates how to perform sacroplasty using the long-axis technique.
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SACRAL INSUFFICIENCY – DIAGNOSIS IS A CONCERN

Difficult to diagnose1

  • Sacral anatomy is poorly delineated on routine sacral X-rays.
  • Patient often lacks a definitive history of trauma.

Prevalence is likely underestimated 1

  • 1.8% of women over the age of 55 years who presented to the hospital with low back pain had sacral fractures.

Potential cost of care is high1

  • Under diagnosis may lead to long-term pain and disability.
  • Inpatient length-of-stay and prolonged disability can further augment cost of patient rehabilitation.

CLINICAL RESULTS

PAIN RELIEF SEEN IN SOME PATIENTS WITHIN 30 MINUTES 3

In a prospective observational cohort study sacroplasty provided rapid pain relief within 30 minutes of the procedure. Reduction in pain levels continued to 52 weeks.

Post-procedure mean scores: repeated measure analysis of variance (p < 0.01)

Sacroplasty Study Results Chart

Study Design

  • Prospective observational cohort study of consecutive patients with osteoporotic sacral insufficiency (SI)
  • n = 52
  • Mean age: 75.9 years
  • Mean symptom duration: 34.5 days

Study Notes

  • Patients attended each follow-up interval (Exception: One patient died after the 2-week follow-up from unrelated pulmonary disease).
  • One case of SI radiculitis occurred due to cement extravasation. This resolved with a single transforaminal epidural steroid injection.

Limitations

  • Randomized controlled trials are needed to evaluate the efficacy of sacroplasty for osteoporotic SI, and to provide an accurate estimate of associated risks.

SIGNIFICANT IMPROVEMENT IN PAIN SCORES AFTER SACROPLASTY 4

In a retrospective multicenter analysis, CT-guided sacroplasty provided prompt and durable pain relief in patients with with SIFs and sacral lesions.. The drop-in pain scores were significant for all groups (P < 0.001).

Fracture Type or Lesion Pre-treatment VAS Score (avg) Post-treatment VAS Score (avg) P value

Bilateral sacral insufficiency fracture

9.2

1.9

< 0.001

Unilateral sacral insufficiency fracture

8.7

2.5

< 0.001

Sacral mass or infiltrative lesion

9.0

2.6

< 0.001

Study Design

  • A retrospective multicenter analysis of consecutive patients with painful SI fractures or lesions
  • n = 204 – SI fracture
  • n = 39 – Sacral lesion
  • Mean age: 77.2 years

Study Notes

  • Complete pain relief was achieved in 31% of patients.
  • The average cement volume used to treat SI fractures was 4.1 ml.*No major complications or procedure-related deaths occurred. One patient treated for an SI fracture experienced radicular pain due to local foraminal cement extravasation. Surgical decompression provided symptomatic relief.
  • One patient had an unsuccessful sacroplasty procedure with subsequent progressive fracture dislocation.

Limitations

  • Limitation: Randomized controlled trials are needed to evaluate the efficacy of sacroplasty for osteoporotic SI, and to provide an accurate estimate of associated risks.
  • Two patients treated with bioceramic bone cement experienced significant pain relief. This number is insufficient to make a conclusion about bioceramic cement in this procedure.

Important Safety Information

The complication rate with Sacroplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal.

Risks of acrylic bone cements include cement leakage, which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as: cardiac arrest, cerebrovascular accident, myocardial infarction, pulmonary embolism, or cardiac embolism.

For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product.

*

Two patients treated with bioceramic bone cement experienced significant pain relief. This number is insufficient to make a conclusion about bioceramic cement in this procedure.

1

Ortiz AO and Brook AL. Sacroplasty. Tech Vasc Interv Radiol. 2009;12(1):51-63. doi: 10.1053.

2

Kortman K, Ortiz O, Miller T, et al. Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg. 2013;5(5):461-466.

3

Frey M, DePalma M, Cifu D, et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study. Spine J. 2008;8(2):367-373.

4

Medtronic data on file: 31100918.