Results of lumbar spondylodeses using different bone grafting materials after transforaminal lumbar interbody fusion (TLIF).

PURPOSE: Can a mixture of hydroxyapatite (HA) and autologous bone from decompression sites produce similar results when used for transforaminal lumbar interbody fusion (TLIF)? In the current literature, autologous iliac crest bone grafts (ICBGs) have been reported the gold standard for this procedure. Indeed, to date, no clinical data have confirmed that a mixture of equal volumes of HA and local autologous bone produce similar results in term of fusion as the same volume of autologous ICBG alone.
METHODS: Study design/setting This study was approved by the local ethics committee and completed in a prospective, randomized, single-blinded manner. The results of lumbar fusion using TLIF and different bone grafting materials were compared. Patient sample The patient sample included patients with spinal lumbar degenerative disease. Outcome measures The clinical outcome was determined using the Oswestry Low Back Pain Disability Questionnaire (ODI) and Visual Analog Scale (VAS). The radiological outcomes and fusion rates were determined with radiographs evaluated using the McAfee criteria and computed tomography (CT) data evaluated by the Williams criteria. Three blinded investigators (one radiologist and two orthopedic surgeons) assessed the data. The secondary variables included donor site morbidity. Methods The patients were admitted to our department for orthopedic surgery with degenerative lumbar pathologies (L2-S1) that required stabilization in one or two segments using a TLIF procedure. The patients were 18-80 years old. Only those patients who had degenerative lumbar pathologies and agreed to be educated about the study were included. The patients were divided into the following two randomized groups: group A: TLIF procedure using autologous ICBGs alone; and group B: TLIF procedure using local bone from decompression site mixed with hydroxyapatite. Each group received equal graft volumes. The mixture in group B consisted of equal volumes of local autograft (5 cc) and synthetic bone (5 cc). A graft volume of 10 cc was used at each fusion level. The patients were followed up at three appointments at 1.5, 6 and 12 months postoperatively. Every patient received detailed education about the course of the study.
RESULTS: Forty-eight patients finished the study (2 patients dropped out). The radiographic fusion rate did not significantly differ between the two groups. Based on the CT criteria, 83.3% of the patients showed fusion in both groups after 12 months. Furthermore, 95.3% of the patients in group A and 91.7% of the patients in group B showed bony spondylodeses according to the radiographic criteria at the 12-month follow-up. The donor site morbidity consisted of one patient with a wound infection and one with a hematoma in group A and two patients with persistent pain in group B. Group A also included one patient with cage subsidence of 4 mm and archived fusion after 12 months. In group B, one patient had a pedicle screw breakage and achieved fusion after 6 months. The clinical outcomes were similar between the two groups. In both groups, the VAS and ODI data improved during the follow-up period (p < 0.05). No patients required additional surgeries.
CONCLUSIONS: Both groups demonstrated equivalent clinical outcomes. HA and autologous bone from decompression sites can achieve similar fusion rates to those achieved with identical volumes of the gold standard autologous graft. The graft mixture can be used for one- or two-level lumbar spondylodeses to avoid donor site morbidity.

RCT Entities:   Population Interventions Outcomes