STUDY DESIGN: A prospective randomized controlled study was carried out. OBJECTIVE: To determine the effectiveness and safety of a tantalum implant in achieving anterior cervical fusion following 1-level discectomy as treatment of degenerative cervical disc disease with radiculopathy. SUMMARY OF BACKGROUND DATA: The gold standard for the treatment of degenerative cervical disc disease could not be already identified. The morbidity of autologous graft and plating, and the doubt about the mechanical efficacy of plate fixation and the clinical benefits in 1-level fusion have promoted the use of other constructs. METHODS: Sixty-one patients were randomized to anterior cervical discectomy and fusion with interbody implant of tantalum (n = 28) or by means of autologous iliac bone graft and plating (n = 33). Fusion rate and segmental height and alignment were blind assessed by radiographs by 2 independent reviewers. Clinical status was evaluated using pain visual analogue scale, the Neck Disability Index, and the Zung Depression Scale. Patient's subjective satisfaction was recorded. Complications and operative parameters were also taken into account. RESULTS: With an endpoint of 24 months, radiologic and clinical outcomes were similar for both treatments without significant difference. The safety of fusion with tantalum implant was obvious, based on the analysis of complications. Complication rate was considerably higher for the autologous graft plus plating procedure than for implant tantalum (P < 0.005). CONCLUSION: The efficacy to achieve fusion after 1-level anterior cervical discectomy, with a good radiologic and clinical outcome, using tantalum implant is equivalent to that of autologous graft and anterior plate, being safer as avoids donor-site graft harvesting and plating complications.
RCT Entities:
STUDY DESIGN: A prospective randomized controlled study was carried out. OBJECTIVE: To determine the effectiveness and safety of a tantalum implant in achieving anterior cervical fusion following 1-level discectomy as treatment of degenerative cervical disc disease with radiculopathy. SUMMARY OF BACKGROUND DATA: The gold standard for the treatment of degenerative cervical disc disease could not be already identified. The morbidity of autologous graft and plating, and the doubt about the mechanical efficacy of plate fixation and the clinical benefits in 1-level fusion have promoted the use of other constructs. METHODS: Sixty-one patients were randomized to anterior cervical discectomy and fusion with interbody implant of tantalum (n = 28) or by means of autologous iliac bone graft and plating (n = 33). Fusion rate and segmental height and alignment were blind assessed by radiographs by 2 independent reviewers. Clinical status was evaluated using pain visual analogue scale, the Neck Disability Index, and the Zung Depression Scale. Patient's subjective satisfaction was recorded. Complications and operative parameters were also taken into account. RESULTS: With an endpoint of 24 months, radiologic and clinical outcomes were similar for both treatments without significant difference. The safety of fusion with tantalum implant was obvious, based on the analysis of complications. Complication rate was considerably higher for the autologous graft plus plating procedure than for implant tantalum (P < 0.005). CONCLUSION: The efficacy to achieve fusion after 1-level anterior cervical discectomy, with a good radiologic and clinical outcome, using tantalum implant is equivalent to that of autologous graft and anterior plate, being safer as avoids donor-site graft harvesting and plating complications.
Authors: Michael F Shriver; Daniel J Lewis; Varun R Kshettry; Benjamin P Rosenbaum; Edward C Benzel; Thomas E Mroz Journal: Global Spine J Date: 2017-02-01