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, 98 (15), e15169

Clinical Outcome of Percutaneous Lumbar Foraminoplasty Using a Safety-Improved Device in Patients With Lumbar Foraminal Spinal Stenosis


Clinical Outcome of Percutaneous Lumbar Foraminoplasty Using a Safety-Improved Device in Patients With Lumbar Foraminal Spinal Stenosis

Yongjae Yoo et al. Medicine (Baltimore).


Lumbar foraminal spinal stenosis (LFSS) is defined as the narrowing of the nerve root exit associated with a herniated intervertebral disc, osteoarthritic changes in the facet joints, or a hypertrophied ligamentum flavum, which can provoke neurogenic claudication. To achieve effective and safe decompression of the lumbar spinal foramen, a specially designed instrument (Claudicare, SEAWON Meditech, Bucheon-si, Gyeonggi-do, Republic of Korea) for percutaneous lumbar foraminoplasty (PLF) was invented. The purpose of this study was to evaluate the clinical efficacy and safety of the newly devised instrument in patients with LFSS.PLF was performed for LFSS by a single pain physician. For each patient, an 11-point numerical rating scale (NRS) pain score-the Oswestry Disability Index (ODI)-and the duration of walking without radicular pain were evaluated at the 3-month follow-up. The successful responder percentage was defined as ≥50% reduction from the baseline NRS score with improvement in ODI and duration of walking.Among 24 patients who underwent PLF, 15 patients showed successful responses. The NRS pain score and duration of walking without radicular pain were improved significantly from baseline at the 3-month follow-up (P < .01). The ODI was also decreased, but the difference was not statistically significant (P = .09). The NRS pain score and walking duration without pain at 3 months were statistically significantly different between the groups (P < .001 and P = .01, respectively), whereas there was no statistically significant difference in improvement in ODI between the groups (P = .23). No serious adverse events occurred in the study.In conclusion, PLF using the Claudicare device may be an optimal and safe option for managing intractable LFSS on an outpatient basis.

Conflict of interest statement

Dr S.E. Sim participated in developing the Claudicare and has a shared patent of the device with the company. The other authors have no conflicts of interest to disclose.


Figure 1
Figure 1
The specially designed instrument for the percutaneous lumbar foraminoplasty procedure. The Claudicare device consists of a guidewire with a less than 1-m diameter, a dilator with a 2-mm diameter, a working cannula (inner/outer diameter: 3 mm/3.5 mm), a drill with a blunt-shaped end and a protection shield, and a disposable battery.
Figure 2
Figure 2
Fluoroscopic images obtained during the percutaneous lumbar foraminoplasty procedure with the Claudicare device. (A) The guidewire was advanced approximately 0.5 cm anteriorly into the target epidural foramen, in the lateral fluoroscopic view. (B) A dilator was inserted via the guidewire into the target foramen until it touched the anterior border of the superior articular process (SAP). (C) After removing the guidewire, a working cannula was inserted via the dilator. The final position of the working cannula was the anterior border of the hypertrophied SAP. (D) A Claudicare drill was inserted via the working cannula and partial removal of the hypertrophied capsule of the SAP commenced from the lateral to medial direction in the AP fluoroscope image.
Figure 3
Figure 3
Schematic drawing of the Claudicare drill working inside the target lesion.
Figure 4
Figure 4
Flow chart of patients in this study.

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