STUDY DESIGN: Retrospective case-control study. PURPOSE: To compare the safety and efficacy of the Zero-profile (Zero-p) integrated plate and spacer device to that of an anterior cervical plate and cage in patients undergoing anterior cervical discectomy and fusion (ACDF). Anterior cervical plating system has provided good results, including higher fusion rate and improved alignment since its use. However, adjacent-level ossification development (ALOD) and dysphagia have been usually reported associating with plates. METHODS: This was a retrospective control study. Sixty-two patients with cervical radiculopathy or myelopathy were treated with an anterior plate and cage or Zero-p implant between January 2011 and December 2011. The mean follow-up was 33.1 months in the plate and cage group and 30.6 months in Zero-p group. Patient demographics, operative details and complications were reviewed. The clinical outcomes were evaluated using the Japanese Orthopaedic Association (JOA) scores and JOA recovery rate before and after operations. Incidence of cephalad and caudal ALOD on the lateral radiographs was studied at preoperation, immediate postoperation and last follow-up. Incidence of dysphagia was also recorded after operation according to Bazaz-Yoo dysphagia index. RESULTS: Thirty-two patients received an anterior plate and cage and 30 received the Zero-p implant. There were no statistical differences in patient demographics, operative details between the two groups. The JOA scores significantly increased compared with preoperational measurements in both groups (p < 0.05), but the JOA recovery rate was similar (72.2 % for plate and cage group and 77.0 % for Zero-p group, p > 0.05). ALOD occurred in 12 (18.8 %) of the 64 cephalad and caudal adjacent segments in plate with cage group, and only 1 (1.6 %) of 63 adjacent levels (including three noncontiguous cases) presented with ALOD in Zero-p group. The difference was significant (p < 0.01). The incidence of dysphagia in the Zero-p group was lower compared with that in the plate with cage group, and the symptom duration was much shorter (p < 0.01). Both groups had no adverse events associated with the implant or implant surgery. CONCLUSIONS: The Zero-profile implant is safe and efficacious after ACDF. It can reduce the rate of adjacent-level ossification development and dysphagia compared to anterior plate and cage.
STUDY DESIGN: Retrospective case-control study. PURPOSE: To compare the safety and efficacy of the Zero-profile (Zero-p) integrated plate and spacer device to that of an anterior cervical plate and cage in patients undergoing anterior cervical discectomy and fusion (ACDF). Anterior cervical plating system has provided good results, including higher fusion rate and improved alignment since its use. However, adjacent-level ossification development (ALOD) and dysphagia have been usually reported associating with plates. METHODS: This was a retrospective control study. Sixty-two patients with cervical radiculopathy or myelopathy were treated with an anterior plate and cage or Zero-p implant between January 2011 and December 2011. The mean follow-up was 33.1 months in the plate and cage group and 30.6 months in Zero-p group. Patient demographics, operative details and complications were reviewed. The clinical outcomes were evaluated using the Japanese Orthopaedic Association (JOA) scores and JOA recovery rate before and after operations. Incidence of cephalad and caudal ALOD on the lateral radiographs was studied at preoperation, immediate postoperation and last follow-up. Incidence of dysphagia was also recorded after operation according to Bazaz-Yoo dysphagia index. RESULTS: Thirty-two patients received an anterior plate and cage and 30 received the Zero-p implant. There were no statistical differences in patient demographics, operative details between the two groups. The JOA scores significantly increased compared with preoperational measurements in both groups (p < 0.05), but the JOA recovery rate was similar (72.2 % for plate and cage group and 77.0 % for Zero-p group, p > 0.05). ALOD occurred in 12 (18.8 %) of the 64 cephalad and caudal adjacent segments in plate with cage group, and only 1 (1.6 %) of 63 adjacent levels (including three noncontiguous cases) presented with ALOD in Zero-p group. The difference was significant (p < 0.01). The incidence of dysphagia in the Zero-p group was lower compared with that in the plate with cage group, and the symptom duration was much shorter (p < 0.01). Both groups had no adverse events associated with the implant or implant surgery. CONCLUSIONS: The Zero-profile implant is safe and efficacious after ACDF. It can reduce the rate of adjacent-level ossification development and dysphagia compared to anterior plate and cage.
Authors: Lawrence J Oh; Sam Ong; Sherief Ghozy; Adam A Dmytriw; Jeffrey Zuccato; Ralph Mobbs; Kevin Phan; Mahmoud Dibas; Harrison Faulkner Journal: J Spine Surg Date: 2020-09