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LANDMARK STUDY DEMONSTRATES BARRICAID SUPERIOR TO GOLD STANDARD

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Two-year definitive results published in The Spine Journal demonstrate superior outcomes when treating patients with Barricaid as compared to discectomy alone.

 

BACKGROUND

Patients with large anular defects (6mm or wider) following lumbar discectomy for disc herniation are at high risk for symptomatic recurrence and reoperation.
 

PURPOSE

To determine whether a bone-anchored anular closure device (Barricaid) in addition to lumbar microdiscectomy resulted in significantly lower reherniation and reoperation rates plus increased overall success compared to lumbar microdiscectomy alone.
 

STUDY DESIGN

  • Randomized superiority trial, compared to standard of care.
  • Multicenter: 21 investigative sites.
  • 550 patients – 1:1 intra-operative randomization to treatment (n=272) or control (n=278).
  • Patients were evaluated preoperatively, at 6 weeks, 3 and 6 months, 1 and 2 years.
  • Skeletally mature patients 21 to 75 years of age, with imaging confirmation of single-level disc herniation between L1 and S1, with disc height ≥ 5mm, and who failed ≥ 6 weeks of nonsurgical treatment.
  • All patients had lumbar radiculopathy with positive straight leg raise or femoral stretch test, and Oswestry Disability Index score (ODI) and Visual Analog Scale (VAS) leg pain score of at least 40/100 on each.
  • Patients with spondylolisthesis (grade II or higher), previous surgery at the index level, and osteoporosis were excluded.
  • Two co-primary endpoints determined a priori were recurrent herniation and a composite endpoint consisting of patient-reported, radiographic, and clinical outcomes.
  • Study success required that outcomes with Barricaid were statistically superior to controls for both endpoints at 2 years follow up.

KEY TRIAL RESULTS

Barricaid demonstrated superiority in overall trial success at 2 years compared to limited discectomy alone. The difference between both groups is statistically superior on all endpoints, in favor of Barricaid.

Frequency of symptomatic reherniation was lower with Barricaid (12% vs 25%, P<0.001).

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Index level reoperations were less frequent with Barricaid (9% vs 16%, P=0.01). 29 reoperations in 24 patients in Barricaid group and 61 reoperations in 45 control patients.

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Frequency of reoperations to address recurrent herniation was 5% with Barricaid and 13% in controls (P=0.001).

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Reoperated patients report significantly more pain, disability and work loss than non-reoperated patients at 2 years.

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SAFETY RESULTS

Frequency of serious adverse events as related to either the implant or procedure was 7% in the Barricaid group and 17% in the control group (P=0.001). This difference was primarily due to the lower incidence of reherniation in the Barricaid group.

No difference in all-cause serious adverse events was observed when comparing Barricaid to controls (25% vs 30%, P=.015).

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RADIOGRAPHIC FINDINGS

Endplate changes were more prevalent in the Barricaid anular closure device group (84% vs 30%, P<0.001), though no correlation with any symptom or clinically adverse event was observed.

 

CONCLUSION

In patients at high risk of herniation recurrence following lumbar microdiscectomy, anular closure with Barricaid significantly lowers the risk of symptomatic recurrence (P<0.001) and reoperation (P=0.01).

Click here for a copy of the publication.

 

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