Authors
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Jiang, Xiaozhou, Office, Research, Office, Research -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2023
INTERVENTION: The study will enroll patients with spine disease, randomize, and assign them to the unilateral biportal endoscopic (UBE) decompression technique treatment group, modification UBE procedure group, and other classic surgery groups. There will then be a period of follow‐up and analysis of the clinical outcomes. UBE lumbar decompression and discectomy. Materials: We used convention 30° 4‐mm rigid arthroscope (BD‐1, ShenDa Endoscope, Shenyang, China), 4.0‐mm oval burr (Sterling, Conmed‐Linvatec, NY, USA), 3.75‐mm radiofrequency ablation probe (Super TURBOVAC 90, Smith & Nephew, London, UK) and instruments tool set for UBE decompression (Blon UBE tool set, Blon, Changzhou, China), including neural dissectors, soft tissue dilator, retractor, rotating Kerrison punches and pituitary forceps. Convention K‐wire for 0.8 mm in diameter and 175 mm in length and a K‐wire bending clamp was also required. Procedures in steps: 1. Endoscopic portals placement: Under image intensification, a spinal needle is inserted in the paraspinal muscles 1 cm parallel to the midline to localize the desired surgical level. After level confirmation, the needle is removed and two portals 5 mm in diameter are formed using a number 15 surgical blade with a 5 mm handle so that it could be advanced to pierce the fascia which is markedly deep in obese patients. The portals are 1 cm lateral to the midline, with the first directly overlying the intervertebral disc and are used for the introduction of the arthroscope and the second is 3–4 cm caudal to the former and is used for the surgical instruments. The 5 mm periosteal elevator is then introduced through the paraspinal muscles without any dissection till it is docked over the CONDITION: Treatment of spine disease with unilateral biportal endoscopic (UBE) decompression technique and other classic surgeries ; Surgery PRIMARY OUTCOME: ; Perioperative data:; 1. Length of operation time measured using medical records after surgery; 2. Endoscopy irrigation amount measured using medical records after surgery; 3. Estimated blood loss measured using medical records after surgery; 4. Complications measured using video records of the endoscopy and clinical charts after surgery; ; Clinical outcomes are assessed at the time of discharge, and at 3, 6, and 12 months and followed by once per year postoperative until the end of this study:; 1. Back pain and lower leg pain measured using a visual analog scale (VAS); 2. Functional recovery measured using the Oswestry Disability Index (ODI); 3. Overall treatment outcomes measured using the modified MacNab criteria; SECONDARY OUTCOME: ; 1. Hemoglobulin concentration in wash out measured using spectrophotometry according to the haemoglobincyanide method after surgery; 2. Amount of bone harvested measured using collecting bone debris and calculated in volume by syringe cylinder after surgery; 3. Accuracy of the pedicle screw placement measured using CT scanning after surgery; 4. Fusion condition measured using CT scanning at 1 year and later follow‐up after surgery; 5. Cross‐section area in decompression segment measured using CT and MRI scanning at 3 months follow‐up after surgery; 6. Irrigation pressure measured using a liquid manometer from a lumbal puncture set during surgery; 7. Supplement in irrigation measured using medical records after surgery; INCLUSION CRITERIA: 1. Neurogenic symptoms induced by lumbar disk herniation 2. Computed tomography and/or magnetic resonance imaging indicating single level LDH, radiologic finding in accordance with clinical neural distribution 3. History of failed conservative treatment 4. Follow‐up for at least 3 months
Epistemonikos ID: bc435c7d7ffa14007bdb32146d8989761b14aaae
First added on: Feb 20, 2024