Comparision of Endoscopic Discectomy and Microdiscectomy for the Treatment of Lumbar Spinal Stenosis

NCT06719037 | Recruiting

• 1 other identifier: KYLL-202208-046-1
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a multicenter comparison of the clinical efficacy of Endo-Surgi Plus endoscopic technique, UBE endoscopic technique, and microdiscectomy technique in the treatment of lumbar spinal stenosis, and to compare the differences in the incidence of complications, surgical trauma, and other aspects among the three surgical techniques for the treatment of lumbar spinal stenosis. Each group of patients received either Endo-Surgi Plus endoscopy, UBE, or microdiscectomy decompression through the Quadrant channel. All patients were routinely administered low-dose hormones, dehydrating agents, and neurotrophic drugs postoperatively. Patients were required to strictly avoid strenuous activities and heavy lifting in the lumbar region for three months after surgery. Upon discharge, patients were provided with the same lumbar and back muscle rehabilitation exercises and other postoperative recovery-related discharge education. Each group of patients was followed up for at least one year, with follow-up including outpatient visits, physical examinations, questionnaire scoring, and necessary auxiliary examinations. Both two endoscopic surgeries, as surgical techniques that have been used in clinical practice for many years, have their efficacy confirmed by various studies. The investigator proposes that these two techniques may have similar clinical efficacy to microdiscectomy, while also offering the advantage of being less invasive. The aim of this study is to validate these assumptions. At the same time, there may be some differences between the two endoscopic surgeries that require further verification.

Conditions

Lumbar Spinal Stenosis

Keywords

Microdiscectomy; Endoscopic; Unilateral Biportal Endoscopic; Endo-surgi Plus endoscopy; ODI; Complication; CK-MB

Outcome Measures

Primary Outcomes (1)

• The Oswestry Disability Index scores

  The maximum score is 100 points, and the minimum score is 0 points. The higher the score, the more severe the functional impairment.

  1 year postoperatively

Secondary Outcomes (10)

• The Oswestry Disability Index scores

  preoperatively, 1 day, 3 months, and 6 months postoperatively

• Visual Analogue Score for lower limb pain/lumbar back pain

  preoperatively, 1 day, 3 months, 6 months, and 1 year postoperatively

• The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36 score)

  preoperatively, 1 day, 3 months, 6 months, and 1 year postoperatively

• Dural sac cross-sectional area calculated from lumbar MRI

  preoperatively and at 1 year postoperatively

• Creatine kinase-MB (CK-MB)

  preoperative and immediate postoperative

Study Arms (3)

Endo-Surgi Plus endoscopic group

EXPERIMENTAL

Procedure: Endo-Surgi Plus endoscopic surgery

Unilateral biportal endoscopic group

EXPERIMENTAL

Procedure: Unilateral biportal endoscopic surgery

Microdiscectomy group

ACTIVE COMPARATOR

Procedure: Microdiscectomy

Interventions

Endo-Surgi Plus endoscopic surgery PROCEDURE

Endo-Surgi Plus endoscopic surgery, as a new type of percutaneous endoscopic lumbar discectomy (PELD), features a larger working channel and represents an optimized single-channel endoscopic technique. However, it still has the limitations inherent in single-channel endoscopy.

Endo-Surgi Plus endoscopic group

Unilateral biportal endoscopic surgery PROCEDURE

Unilateral biportal endoscopic discectomy (UBE) is characterized by its separate endoscopic and working channels, and the ability to use traditional open instruments, making it a convenient and versatile technique. It is a commonly used spinal endoscopic surgery in clinical practice.

Unilateral biportal endoscopic group

Microdiscectomy PROCEDURE

Microdiscectomy (MD) is a mature minimally invasive technique that uses a microscope to treat lumbar spinal stenosis. As early as 1999, prospective randomized controlled studies confirmed that it has equally excellent clinical efficacy compared to open surgery, with less surgical trauma. It is currently the classic minimally invasive surgical approach for treating lumbar spinal stenosis.

Microdiscectomy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with single-segment lumbar spinal stenosis through CT and MRI imaging combined with clinical symptoms;
• Symptoms in the lumbar region and lower extremities corresponding to the imaging findings;
• Patients who have not responded to three months of conservative treatment;
• Informed consent from family members regarding the surgical procedure and associated risks.

You may not qualify if:

• Patients with multi-segment lumbar disc herniation, malignant spinal tumors, spinal deformities, and other diseases.
• Patients with comorbidities such as cardiovascular diseases, cerebrovascular diseases, or those with mental abnormalities, communication difficulties, or other issues that may affect clinical evaluation.
• Patients with a history of previous lumbar surgery.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (5)

• Han S, Zeng X, Zhu K, Wu X, Shen Y, Han J, Lin A, Meng S, Zhang H, Li G, Liu X, Tao H, Ma X, Zhou C. Clinical Application of Large Channel Endoscopic Systems with Full Endoscopic Visualization Technique in Lumbar Central Spinal Stenosis: A Retrospective Cohort Study. Pain Ther. 2022 Dec;11(4):1309-1326. doi: 10.1007/s40122-022-00428-3. Epub 2022 Sep 3.

  PMID: 36057015 BACKGROUND

• Katz JN, Zimmerman ZE, Mass H, Makhni MC. Diagnosis and Management of Lumbar Spinal Stenosis: A Review. JAMA. 2022 May 3;327(17):1688-1699. doi: 10.1001/jama.2022.5921.

  PMID: 35503342 BACKGROUND

• Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022 Dec 13;328(22):2252-2264. doi: 10.1001/jama.2022.21022.

  PMID: 36511921 BACKGROUND

• Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.

  PMID: 27074067 BACKGROUND

• Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.

  PMID: 27074066 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Xinyu Yang, M.D.

CONTACT

+8618560089496; dr_xinyuyang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 5, 2024
• Study Start: December 8, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-11

Locations

CN (1)