Thomas P Loumeau1, Bruce V Darden2, Thomas J Kesman1, Susan M Odum3, Bryce A Van Doren3, Eric B Laxer1, Daniel B Murrey4. 1. OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA. 2. OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA. bruce.darden@orthocarolina.com. 3. OrthoCarolina Research Institute, 2001 Vail Avenue, Suite 300, Charlotte, NC, 28207, USA. 4. OrthoCarolina, PA, 4601 Park Road, Suite 300, Charlotte, NC, 28209, USA.
Abstract
PURPOSE: The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7. METHODS: We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed. RESULTS: Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received theProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group. CONCLUSIONS: The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.
RCT Entities:
PURPOSE: The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7. METHODS: We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed. RESULTS: Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group. CONCLUSIONS: The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.
Entities:
Keywords:
Anterior cervical discectomy and fusion; Clinical trial; Outcomes; ProDisc-C; Symptomatic cervical disc disease; Total disc arthroplasty
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