Lumbar Discectomy With Bone-Anchored Annular Closure Device in Patients With Large Annular Defects: One-Year Results

Area of Science:

• Spinal surgery outcomes
• Biomaterials in orthopedic devices
• Minimally invasive spine procedures

Background:

• High reherniation risk in lumbar discectomy patients with large annular defects.
• Bone-anchored annular closure devices (ACD) showed promise in prior RCTs for reducing reherniation and reoperation.
• Previous randomized controlled trial (RCT) indicated ACDs lower symptomatic reherniation and serious adverse events (SAEs).

Purpose of the Study:

• Evaluate the real-world use of bone-anchored ACDs during discectomy.
• Confirm prior RCT findings on ACD efficacy and safety.
• Assess ACD impact on reherniation, reoperation, and patient-reported outcomes.

Main Methods:

• Prospective, post-market, historically controlled study design.
• 55 patients received discectomy with a bone-anchored ACD.
• Comparison with 262 patients (discectomy + ACD) and 272 patients (discectomy alone) from a prior RCT.

Main Results:

• Significantly lower reherniation/reoperation rates in the ACD group compared to RCT-ACD and RCT-Control (p < 0.05).
• One-year symptomatic reherniation rate: 3.7% (ACD) vs. 8.5% (RCT-ACD) vs. 17.0% (RCT-Control).
• One-year reoperation rate: 5.5% (ACD) vs. 6.5% (RCT-ACD) vs. 12.5% (RCT-Control); no device-related SAEs.

Conclusions:

• Bone-anchored ACDs demonstrate low rates of reherniation, reoperation, and SAEs in patients with large annular defects.
• Post-market study confirms ACDs reduce reherniation/reoperation and improve back pain compared to RCT data.
• ACD implantation is associated with clinically meaningful improvements in patient-reported disability, pain, and quality of life.