Development of percutaneously insertable/removable interspinous process spacer for treatment of posture-dependent lumbar spinal-canal stenosis: preclinical feasibility study using porcine model. 2012

Kotaro Nishida, and Minoru Doita, and Kenichiro Kakutani, and Koichiro Maeno, and Takashi Yurube, and Masahiro Kurosaka
Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan. kotaro@med.kobe-u.ac.jp

OBJECTIVE A procedure using an interspinous process spacer (IPS) was recently developed for the treatment of posture-dependent lumbar spinal-canal stenosis (LSS) patients. We developed a novel IPS which can be inserted with simpler procedures and removed percutaneously. The objectives of this study were: (1) to evaluate the feasibility and safety of this novel technique, and (2) to assess the effectiveness of this spacer in terms of preventing an increase of epidural pressure in lumbar extension using a porcine model. METHODS Eight young pigs were used. Under general anesthesia and image guidance, the spacers were inserted. Three months after operation, MR images were taken and all spacers were removed. Blood samples were obtained before and 1, 3, 7 days after surgery. After killing the animals, the lumbar spines were observed macroscopically. Another six animals were used. Under general anesthesia and image guidance, a flexible pressure transducer was inserted into the epidural space and epidural pressure was measured in neutral and at maximum extension with and without spacer insertion. RESULTS Percutaneous insertion and removal of the spacer was successful for all animals through small skin incisions. MR images showed minimal damage to the muscle. No significant up-regulation of Interleukin-6 (IL-6) and CRP was detected. Macroscopic observation of the lumbar spine 3 months after the operation revealed that the area of the interspinous process contacting with the inserted spacer showed some bone erosion/remodeling. Insertion of the spacer did not affect the epidural pressure in neutral but significantly prevented an increase of epidural pressure in lumber extension. CONCLUSIONS This study demonstrated that the percutaneous insertion and removal of a novel IPS was feasible and safe using a simple technique. Furthermore, this procedure can be recognized as minimally invasive surgery from the viewpoint of skin incision, short insertion track, inflammatory mediators, and muscle damage. Improvements should be attempted in future studies using softer or more elastic materials for the spacer to lessen bone erosion/remodeling at contacting area of the inserted spacer.

UI MeSH Term Description Entries
D008159 Lumbar Vertebrae VERTEBRAE in the region of the lower BACK below the THORACIC VERTEBRAE and above the SACRAL VERTEBRAE. Vertebrae, Lumbar
D011187 Posture The position or physical attitude of the body. Postures
D004195 Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases. Animal Disease Model,Animal Disease Models,Disease Model, Animal
D005240 Feasibility Studies Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project. Feasibility Study,Studies, Feasibility,Study, Feasibility
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D013130 Spinal Stenosis Narrowing of the spinal canal. Spinal Stenoses,Stenoses, Spinal,Stenosis, Spinal
D013552 Swine Any of various animals that constitute the family Suidae and comprise stout-bodied, short-legged omnivorous mammals with thick skin, usually covered with coarse bristles, a rather long mobile snout, and small tail. Included are the genera Babyrousa, Phacochoerus (wart hogs), and Sus, the latter containing the domestic pig (see SUS SCROFA). Phacochoerus,Pigs,Suidae,Warthogs,Wart Hogs,Hog, Wart,Hogs, Wart,Wart Hog
D016268 Internal Fixators Internal devices used in osteosynthesis to hold the position of the fracture in proper alignment. By applying the principles of biomedical engineering, the surgeon uses metal plates, nails, rods, etc., for the correction of skeletal defects. Fixation Devices, Internal,Device, Internal Fixation,Devices, Internal Fixation,Fixation Device, Internal,Fixator, Internal,Fixators, Internal,Internal Fixation Device,Internal Fixation Devices,Internal Fixator
D019060 Minimally Invasive Surgical Procedures Procedures that avoid use of open, invasive surgery in favor of closed or local surgery. These generally involve use of laparoscopic devices and remote-controlled manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device. Minimal Access Surgical Procedures,Minimal Surgical Procedures,Minimally Invasive Surgical Procedure,Surgical Procedures, Minimally Invasive,Minimal Surgical Procedure,Minimally Invasive Surgery,Procedure, Minimal Surgical,Procedures, Minimal Access Surgical,Procedures, Minimal Surgical,Procedures, Minimally Invasive Surgical,Surgical Procedure, Minimal,Surgical Procedures, Minimal,Surgical Procedures, Minimal Access,Minimally Invasive Surgeries,Surgeries, Minimally Invasive,Surgery, Minimally Invasive

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