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Two systems for single-segment cervical disc arthroplasty found clinically comparable
Chinese researchers who studied the safety and effectiveness of two different cervical total disc arthroplasty systems used for single-segment cervical disc replacement found that both systems displayed similar clinical effectiveness and safety.
In the study, they compared the Bryan Cervical Disc System (Medtronic Inc., Minneapolis, Minn.) and the ACCEL system from Medtronic. They noted the ACCEL system appeared to have the advantages of a shorter operative time and less blood loss.
This is the first time the two systems were clinically compared for safety and effectiveness, the authors noted.
Rui Shi, MD, and colleagues studied 50 patients (28 men, 22 women) who responded poorly to conservative treatment and underwent one-level cervical total disc replacement with either the Bryan Cervical Disc System or the ACCEL system, based on details of the study.
The Bryan Cervical Disc System is FDA approved, but the ACCEL system is not although it is approved in China, Shi and colleagues wrote in the study.
Twenty-four patients were treated with the Bryan Cervical Disc System and 26 patients were treated with the ACCEL system. The most commonly treated level was C-5-6.
Shi and colleagues measured the patients’ outcomes and other factors preoperatively and at 2 weeks and 6, 12, and 24 months postoperatively. The patients’ symptoms, radiographic results, and quality of life were evaluated by a trained physician, they noted.
“In the current study, both the group treated with the Bryan Cervical Disc System and the group treated with the ACCEL system achieved satisfactory clinical outcomes, including significant pain relief, cervical function improvement, and quality of life amelioration, consistent with the results of previous studies. The 2 implantation systems had the same clinical effectiveness over the 2-year follow-up period,” Shi and colleagues wrote.
As noted in the study, implanting the Bryan Cervical Disc System involves six major surgical steps and the ACCEL System omits three of those steps from the procedure.
“For single-level replacement, the ACCEL system took an average of 27 minutes less operative time than did the Bryan Cervical Disc System and had half the blood loss. Reduced operative time is generally associated with less blood loss,” Shi and colleagues wrote.
The authors noted that although the ACCEL system may have a shorter average operative time and less blood loss, this needs to be confirmed by larger studies. – Robert Linnehan
Disclosure: The authors have no relevant financial relationships to disclose.
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Shi R. Orthopedics. 2014. DOI: 10.3928/01477447-20140124-20.