Clinical efficacy and safety of a new flexible interbody spacer system.

Background: Patients with lumbar degenerative disk disease (DDD) often require an interbody fusion. Several spacer systems have been developed to achieve an adequate fusion. The newly developed flexible interbody spacer system (Luna®, Benvenue Medical Inc.) expands to the disk space and is adjustable to the patient's anatomy.

Objective: Prospective monocentric evaluation of interbody fusions performed with the new system in patients with DDD to assess the device's efficacy and safety.

Methods: The study includes patients with DDD of one or two contiguous lumbar levels. All patients were treated with the new flexible cage system. To evaluate the clinical outcome, examinations were conducted preoperatively, 6 weeks, 6 months and 12 months postoperatively. At each study visit possible implant loosening was assessed by plain radiography and any adverse events were documented. Furthermore, back pain was evaluated using the visual analogue scale (VAS), functional impairment using the Oswestry-Disability-Index (ODI) and quality of life using the SF36.

Results: A total of 30 patients (age: 52.8 ± 11 years, gender: 53% male) were included. None of the patients showed signs of implant loosening and the total number of adverse events was low (3%). The VAS improved significantly from 81.2 ± 9.5 mm at baseline to 28 ± 26.2 mm after 12-months (p ≤ 0.0001). The ODI also improved significantly from 57.9 ± 9.6% at baseline to 20 ± 15.6% after 12-months (p ≤ 0.0001). The physical component score (PCS) of the SF36 improved significantly ongoing from 29.2 ± 9.3 at baseline to 56.1 ± 14.9 after 12-months (p = 0.0079) and the mental component score (MCS) improved significantly from 49.2 ± 20.7 at baseline to 62.8 ± 18.9 after 12 months (p = 0.013).

Conclusions: Minimal-invasive lumbar interbody fusion with the new flexible system is a safe and effective treatment method for patients with DDD. Complication rates are low and treatment leads to an improvement of pain, functional impairment and quality of life.