Lumbar disc reherniation prevention with a bone-anchored annular closure device: 1-year results of a randomized trial

Wimar van den Brink, Charlotte Flüh, Larry E Miller, Peter Douglas Klassen, Richard Bostelmann, Wimar van den Brink, Charlotte Flüh, Larry E Miller, Peter Douglas Klassen, Richard Bostelmann

Abstract

Background: The risk of recurrent herniation after lumbar discectomy is highest during the first postoperative year. The purpose of this study was to determine whether implantation of a bone-anchored annular closure device (ACD) following limited lumbar discectomy reduced the risk of recurrent herniation and complications during the first year of follow-up compared to limited lumbar discectomy alone (Controls) and whether this risk was influenced by patient characteristics.

Methods: In this randomized multicenter trial, patients with symptomatic lumbar disc herniation and with a large annular defect following limited lumbar discectomy were randomized to bone-anchored ACD or Control groups. The risks of symptomatic reherniation, reoperation, and device- or procedure-related serious adverse events were reported over 1 year of follow-up.

Results: Among 554 patients (ACD 276; Control 278), 94% returned for 1-year follow-up. Bone-anchored ACD resulted in lower risks of symptomatic reherniation (8.4% vs. 17.3%, P = .002) and reoperation (6.7% vs. 12.9%, P = .015) versus Controls. Device- or procedure-related serious adverse events through 1 year were reported in 7.1% of ACD patients and 13.9% of Controls (P = .009). No baseline patient characteristic significantly influenced these risks.

Conclusions: Among patients with large annular defects following limited lumbar discectomy, additional implantation with a bone-anchored ACD lowered the risk of symptomatic reherniation and reoperation over 1 year follow-up. Device- or procedure-related serious adverse events occurred less frequently in the ACD group. These conclusions were not influenced by patient characteristics. ClinicalTrials.gov (NCT01283438).

Conflict of interest statement

LM and PK received personal fees from Intrinsic Therapeutics. WB, CF, and RB report no conflicts of interest.

Figures

Figure 1
Figure 1
Lateral radiograph showing the bone-anchored annular closure device implanted at L4-L5. Graphic representation of the boneanchored annular closure device, with a titanium bone anchor holding the polyester mesh in place (left panel). Lateral radiograph showing the boneanchored annular closure device implanted at L4L5 (right panel).
Figure 2
Figure 2
CONSORT flow diagram of patient enrollment and randomization into treatment groups. Compliance with clinical follow-up at 1 year was 95% with annular closure device and 94% with controls.
Figure 3
Figure 3
Cumulative risk of symptomatic reherniation over 1-year post-treatment. Risk of symptomatic herniation was 8.4% (standard error 1.7%) with annular closure device and 17.3% (standard error 2.3%) with Controls. Log-rank P = .002.
Figure 4
Figure 4
Hazard ratio for symptomatic reherniation with annular closure device vs controls by baseline patient characteristics. ACD = annular closure device; BMI = body mass index; ODI = Oswestry Disability Index. Plotted values are hazard ratio and 95% confidence interval. Hazard ratio  1 indicates higher risk with ACD. Continuous variables are categorized by the median value.
Figure 5
Figure 5
Cumulative risk of reoperation over 1-year post-treatment. Risk of symptomatic herniation was 6.7% (standard error 1.5%) with annular closure device and 12.9% (standard error 2.0%) with controls. Log-rank P = .015.
Figure 6
Figure 6
Hazard ratio for reoperation with annular closure device vs. controls by baseline patient characteristics. ACD = annular closure device; BMI = body mass index; ODI = Oswestry Disability Index. Plotted values are hazard ratio and 95% confidence interval. Hazard ratio  1 indicates higher risk with ACD. Continuous variables are categorized by the median value.
Figure 7
Figure 7
Cumulative risk of device- or procedure-related serious adverse event over 1-year post-treatment. Risk of device- or procedure-related serious adverse event was 7.1% (standard error 1.6%) with annular closure device and 13.9% (standard error 2.1%) with controls. Log-rank P = .009.
Figure 8
Figure 8
Hazard ratio for device- or procedure-related serious adverse event with annular closure device vs. controls by baseline patient characteristics. ACD = annular closure device; BMI = body mass index; ODI = Oswestry Disability Index. Plotted values are hazard ratio and 95% confidence interval. Hazard ratio  1 indicates higher risk with ACD. Continuous variables are categorized by the median value.

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