STUDY DESIGN: A prospective, randomized, multicenter, FDA-regulated Investigational Device Exemption clinical trial. OBJECTIVES: To analyze the incidence of, and reasons for, reoperation in all patients (treatment and control) enrolled in the IDE study. SUMMARY OF BACKGROUND DATA: This is the first report of the incidence and nature of reoperations following lumbar TDR as part of a controlled, prospective, multicenter trial. METHODS: A total of 688 patients meeting the inclusion and exclusion criteria were enrolled in one of three arms of the study at 14 centers across the United States. This cohort includes 71 nonrandomized cases, 205 randomized cases, and 313 continued access cases, all receiving the CHARITE Artificial Disc, as well as 99 randomized cases in thecontrol group (ALIF with threaded fusion cages and autograft). A detailed analysis was performed of clinical chart notes, operative notes, and adverse event reports for all patients requiring reoperation following their index surgery. RESULTS: Of the 589 patients with TDR, 52 (8.8%) required reoperation. Of the 99 patients with lumbar fusion, 10 (10.1%) required reoperation, and an additional 2 required surgery for adjacent level disease (P = 0.7401). There were 24 TDR patients who underwent a repeated anterior retroperitoneal approach, with 22 (91.7%) having had a successful removal of the prosthesis. Seven of the 24 TDR prostheses requiring removal were revised to another CHARITE Artificial Disc. The mean time to reoperation in all patients was 9.7 months. A total of 29 patients (4.9%) in the TDR group required posterior instrumentation and fusion as did 10 (10.1%) in the control group (P = 0.0562). At 2 years or more follow-up, 93.9%(553/589 = 93.9%) of patients receiving TDR with the CHARITE Artificial Disc had a successfully functioning prosthesis with a mean of over 7 degrees of flexion-extension mobility. CONCLUSIONS: Lumbar TDR with the CHARITE Artificial Disc did not preclude any further procedures at the index level during primary insertion, with nearly one third being revisable to a new motion-preserving prosthesis and just over two thirds being successfully converted to ALIF and/ or posterior pedicle screw arthrodesis, the original alternative procedure.
RCT Entities:
STUDY DESIGN: A prospective, randomized, multicenter, FDA-regulated Investigational Device Exemption clinical trial. OBJECTIVES: To analyze the incidence of, and reasons for, reoperation in all patients (treatment and control) enrolled in the IDE study. SUMMARY OF BACKGROUND DATA: This is the first report of the incidence and nature of reoperations following lumbar TDR as part of a controlled, prospective, multicenter trial. METHODS: A total of 688 patients meeting the inclusion and exclusion criteria were enrolled in one of three arms of the study at 14 centers across the United States. This cohort includes 71 nonrandomized cases, 205 randomized cases, and 313 continued access cases, all receiving the CHARITE Artificial Disc, as well as 99 randomized cases in the control group (ALIF with threaded fusion cages and autograft). A detailed analysis was performed of clinical chart notes, operative notes, and adverse event reports for all patients requiring reoperation following their index surgery. RESULTS: Of the 589 patients with TDR, 52 (8.8%) required reoperation. Of the 99 patients with lumbar fusion, 10 (10.1%) required reoperation, and an additional 2 required surgery for adjacent level disease (P = 0.7401). There were 24 TDR patients who underwent a repeated anterior retroperitoneal approach, with 22 (91.7%) having had a successful removal of the prosthesis. Seven of the 24 TDR prostheses requiring removal were revised to another CHARITE Artificial Disc. The mean time to reoperation in all patients was 9.7 months. A total of 29 patients (4.9%) in the TDR group required posterior instrumentation and fusion as did 10 (10.1%) in the control group (P = 0.0562). At 2 years or more follow-up, 93.9%(553/589 = 93.9%) of patients receiving TDR with the CHARITE Artificial Disc had a successfully functioning prosthesis with a mean of over 7 degrees of flexion-extension mobility. CONCLUSIONS: Lumbar TDR with the CHARITE Artificial Disc did not preclude any further procedures at the index level during primary insertion, with nearly one third being revisable to a new motion-preserving prosthesis and just over two thirds being successfully converted to ALIF and/ or posterior pedicle screw arthrodesis, the original alternative procedure.
Authors: Ilona Punt; Ryan Baxter; André van Ooij; Paul Willems; Lodewijk van Rhijn; Steven Kurtz; Marla Steinbeck Journal: Acta Biomater Date: 2011-05-20 Impact factor: 8.947