Kagaya H, Sharma M, Polando G, Marsolais E B
Veterans Administration Medical Center, Cleveland, OH 44106-1702, USA.
Clin Orthop Relat Res. 1998 Jan(346):215-22.
The reliability of a closed double helix electrode in the lower limbs was studied. This electrode is an implanted intramuscular electrode and is used for a totally implantable functional electrical stimulation system. Eighty electrodes were evaluated retrospectively with a mean period of 15 months. The total implant time was 1222 electrode months. The cumulative proportion surviving was 0.934 at 6 months, 0.855 at 1 year, 0.765 at 2 years, and 0.730 after 30 months. Fifteen of 80 electrodes failed, seven showed increasing electrode impedance, and eight had undesirable changes in recruitment. Of the failed electrodes, 2/3 failed during the first 10 months. The reliability was 0.91 at 6 months and 0.80 at 1 year after implantation in all muscle groups. The closed double helix electrode displayed an increased reliability when compared with the open double helix electrode at 6 months, and an equivalent reliability as compared with the electrodes developed by Handa and colleagues at 6 months and 1 year, using the chi squared test for independence. This study suggests that the closed double helix electrode has an acceptable reliability and can be used as a part of a totally implantable functional electrical stimulation system.
对下肢闭合双螺旋电极的可靠性进行了研究。该电极是一种植入式肌内电极，用于完全植入式功能性电刺激系统。对80个电极进行了回顾性评估，平均随访时间为15个月。总植入时间为1222电极月。6个月时累积存活比例为0.934，1年时为0.855，2年时为0.765，30个月后为0.730。80个电极中有15个失效，7个显示电极阻抗增加，8个在募集方面有不良变化。在失效的电极中，2/3在最初10个月内失效。所有肌肉组植入后6个月时可靠性为0.91，1年时为0.80。使用卡方独立性检验，与开放双螺旋电极相比，闭合双螺旋电极在6个月时显示出更高的可靠性，与Handa及其同事开发的电极在6个月和1年时相比，可靠性相当。本研究表明，闭合双螺旋电极具有可接受的可靠性，可作为完全植入式功能性电刺激系统的一部分使用。
