gms | German Medical Science

Background: ALIF procedures have been first described by Cloward in 1950. The potential advantage of the technique is the restoration of the sagittal alignment in combination with the possibility to insert a large interbody fusion device without compromising the back musculature and neural structures. The rising aviability of new materials, including titanium coated peek cages with integrated screw fixation opens the theoretical opportunity to provide enough primary stability to the construct without supplemental fixation.

Materials and Methods: We conducted a multi-center prospective trial in wich 32 patients with low back pain scheduled for monosegmental lumbar interbody fusion with a titanium coated peek cage with integrated screws, filled with bone substitute. Study eligibility required at least 6 months of conservative treatment. The primary outcome parameter was ODI at 2 years. Secondary outcome parameters included VAS back, VAS leg, neurological outcome and radiographic analysis provided by an independent core lab. Study success required improvement of 15/100 in ODI. Ethic committee approval was obtained in both centers. The monitoring of data was conducted by a core lab.

Results: The endpoint of the study was met, with a reduction of the mean ODI Score from 41.1 to 19.2. The mean VAS back decreased from 62,8 to 28,2 and the mean VAS leg decreased from 49,3 to 20,3. The mean increase of lumbar lordosis was 7,03°. Criteria for fusion where met in 83% (ROM <4°). 9 of 10 patients undergoing a CT scan at 24 months showed bone bridging of the segment. One patient suffered a vascular complication leading to a supferficial wound infection and one patient suffered a vertebral fracture leading to posterior decompression and instrumentation.

Conclusion: ALIF with stand alone titanium coated peek cages with integrated screw fixation is effective for the treatment of back pain in the presence of acceptable complication rate.