Affiliations: Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn, Bonn, Germany
Correspondence:
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Corresponding author: Robert Pflugmacher, Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn, Sigmund-Freud-Str.25, 53127 Bonn, Germany. Tel.: +49 0151 58 233 263; Fax: +49 0228 287 14175; E-mail:[email protected]
Abstract: 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.
Keywords: Degenerative disk disease, flexible interbody fusion
