Transforaminal Lumbar Interbody Fusion With Viable Allograft: 75 Consecutive Cases at 12-Month Follow-up.

BACKGROUND: When conservative treatments fail to alleviate the discomfort of abnormal motion, spinal fusion has been shown to provide symptomatic treatment for spinal instability, stenosis, spondylolisthesis, and symptomatic degenerative disc disease. The trend and rates of fusion over the past few years have been dramatic in the United States. Accompanying that higher incidence has been the shifting from traditional open surgery to minimally invasive techniques to reduce scar tissue formation, extent of muscle stripping, and muscle retraction which all have been shown to adversely affect outcomes. Other reasons supporting the widespread transition to minimally invasive surgical (MIS) techniques include decreased postoperative pain, decreased intraoperative blood loss, shorter postoperative hospital stay, faster return to normal activity, and reduced reoperation rates. Spinal fusion procedures rely on a bony fusion substrate in addition to fixation hardware. While available grafting options include autogenous, allogeneic, and synthetic materials, recent interest in viable allograft material with living cells has drawn attention and attraction for incorporating a biologic basis for regenerative consideration. A recent viable allograft, complete with cellular and designated bone carrier (VIA Graft, Vivex Biomedical, Marietta, Georgia) has been developed. This study represents a retrospective review of a single-practice, single-surgeon evaluation of the product in 75 consecutive patients for fusion by computed tomography (CT) and radiographic evaluation at 12 months in conjunction with a MIS approach. Viable allograft was used to fill the peri-implant space, and central implant lumen was filled with a cancellous bone sponge soaked in perivertebral bone marrow. Posterolateral supplementation was attained with beta-tricalcium phosphate as a bulking agent.
METHODS: A retrospective review identified patients treated for both primary and revision surgery who received VIA Graft cellular bone matrix material in minimally invasive interbody fusion (MIS-TLIF) with a minimum of 12-month follow up. The patient diagnoses included radiculopathy in all instances and varied collateral indications such as foraminal collapse, recurrent disc herniation, and spondylolisthesis to which pain and morbidity had been unresolved by conservative treatment. Adverse events including infection, revisions, and evidence of immune response were evaluated and patient comorbidities defined for the entire population of patients. Patient fusion status was assessed using thin slice CT by 2 independent radiologists separate from the surgeon. There were 75 consecutive adult patients with degenerative conditions of the lumbar spine who underwent MIS-TLIF surgery of which 40 (53%) were male and 35 (47%) were female. Mean age, height, and weight were 58 years, 170.18 cm (67 in), and 88.45 kg (195 lbs), respectively. The mean body mass index was 30. There were 16 patients (21%) who smoked and 12 (16%) with a history of diabetes. Independent blinded review of fusion was obtained by a board certified musculoskeletal radiologist and an experienced board certified orthopaedic surgeon to assess patient fusion status. Spinal segments were deemed fused if 12-month CT scans demonstrated evidence of bridging bone at the fusion site without observed motion on flexion-extension radiographs. Findings such as osteolysis around the implant or pedicle screws, extensive endplate cystic changes, or linear defects parallel to the endplates through intradiscal new bone formation were interpreted as signs of pseudarthrosis. Interobserver and intraobserver error and κ assessments were analyzed to assure agreement in the CT outcomes assessment where interpretation of κ were as follows: <0.00 = poor agreement, 0.00-0.20 = slight agreement, 0.21-0.40 = fair agreement, 0.41-0.60 = moderate agreement, 0.61-0.80 = substantial agreement, and 0.81-1.00 = almost perfect agreement. Differences were resolved by consensus amongst the observers.
RESULTS: In total, 96% of the 75 patients with a total of 85 levels (96.5% of levels treated) achieved a fusion at 12 months. There were no perioperative or latent complications and no transfusions in all 75 patients.
CONCLUSIONS: In this population, 96% of the patients treated achieved the surgical objective in 96.5% of the levels treated. LEVEL OF EVIDENCE: IV. CLINICAL RELEVANCE: The high rate of fusion, the lack of secondary morbidity with autologous bone harvest, and the clinical success account for the benefits of viable allograft matrix for MIS-TLIF use.