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.
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