Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocol
Introduction Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique have both been used to treat lumbar spinal stenosis (LSS) with satisfactory outcomes. Although previous studies have reported no difference in clinical outcomes between UBE and UE techniques, the evid...
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BMJ Publishing Group
2025-07-01
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| author | Xiang Li Yong Yang Lingjia Yu Haining Tan Yuquan Liu Guangpeng Li Yuanshun Lo Zhu Bin |
| author_facet | Xiang Li Yong Yang Lingjia Yu Haining Tan Yuquan Liu Guangpeng Li Yuanshun Lo Zhu Bin |
| author_sort | Xiang Li |
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| description | Introduction Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique have both been used to treat lumbar spinal stenosis (LSS) with satisfactory outcomes. Although previous studies have reported no difference in clinical outcomes between UBE and UE techniques, the evidence was weak due to the lack of a prospective design. Therefore, the present prospective study aimed to compare the efficacy and safety of UBE and UE for treating patients with LSS.Methods and analysis This single-centre, prospective, non-randomised cohort trial is designed to compare the efficacy and safety of UBE and UE in treating patients with LSS. We will include 120 participants (60 per group) with single-level or double-level LSS. The primary outcome will be determined using the Oswestry Disability Index at the 12-month postoperative follow-up between the two groups. Secondary outcomes will include the following: visual analogue scale scores for lower back and leg pain, Japanese Orthopaedic Association score, modified MacNab criteria, Medical Outcomes Study 36-Item Short Form Health Survey, operation time, blood loss and duration of postoperative hospital stay. Radiographic outcomes will include the enlargement ratio of the dural sac, bony decompression range and preservation rate of the facet joint measured on postoperative radiological data. Laboratory outcomes will include postoperative creatine kinase level and erythrocyte sedimentation rate. Adverse events will be recorded to assess safety. Participants will be assessed by a blinded assessor preoperatively and postoperatively at 3 days, 2 weeks, 1, 3, 6 and 12 months.Ethics and dissemination This study received approval from the Institutional Review Board of Beijing Friendship Hospital, Capital Medical University (2022-P2-336-02). All participants will provide informed consent prior to enrolment, and the study will be conducted in strict accordance with the Declaration of Helsinki. Study results will be disseminated via peer-reviewed publications and presentations at academic conferences.Trial registration number ClinicalTrials.gov (NCT06365229) and Chinese Clinical Trial Registry (ChiCTR2200066192). |
| format | Article |
| id | doaj-art-474da4f6845a41479f8ced32ea1ef507 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-474da4f6845a41479f8ced32ea1ef5072025-08-20T02:47:13ZengBMJ Publishing GroupBMJ Open2044-60552025-07-0115710.1136/bmjopen-2024-087863Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocolXiang Li0Yong Yang1Lingjia Yu2Haining Tan3Yuquan Liu4Guangpeng Li5Yuanshun Lo6Zhu Bin7Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, ChinaDepartment of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, ChinaDepartment of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, ChinaDepartment of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, ChinaDepartment of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, ChinaDepartment of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, ChinaDivision of Spine Surgery, Department of Orthopedic Surgery, China Medical University Beigang Hospital, China Medical University, Yunlin, TaiwanDepartment of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, ChinaIntroduction Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique have both been used to treat lumbar spinal stenosis (LSS) with satisfactory outcomes. Although previous studies have reported no difference in clinical outcomes between UBE and UE techniques, the evidence was weak due to the lack of a prospective design. Therefore, the present prospective study aimed to compare the efficacy and safety of UBE and UE for treating patients with LSS.Methods and analysis This single-centre, prospective, non-randomised cohort trial is designed to compare the efficacy and safety of UBE and UE in treating patients with LSS. We will include 120 participants (60 per group) with single-level or double-level LSS. The primary outcome will be determined using the Oswestry Disability Index at the 12-month postoperative follow-up between the two groups. Secondary outcomes will include the following: visual analogue scale scores for lower back and leg pain, Japanese Orthopaedic Association score, modified MacNab criteria, Medical Outcomes Study 36-Item Short Form Health Survey, operation time, blood loss and duration of postoperative hospital stay. Radiographic outcomes will include the enlargement ratio of the dural sac, bony decompression range and preservation rate of the facet joint measured on postoperative radiological data. Laboratory outcomes will include postoperative creatine kinase level and erythrocyte sedimentation rate. Adverse events will be recorded to assess safety. Participants will be assessed by a blinded assessor preoperatively and postoperatively at 3 days, 2 weeks, 1, 3, 6 and 12 months.Ethics and dissemination This study received approval from the Institutional Review Board of Beijing Friendship Hospital, Capital Medical University (2022-P2-336-02). All participants will provide informed consent prior to enrolment, and the study will be conducted in strict accordance with the Declaration of Helsinki. Study results will be disseminated via peer-reviewed publications and presentations at academic conferences.Trial registration number ClinicalTrials.gov (NCT06365229) and Chinese Clinical Trial Registry (ChiCTR2200066192).https://bmjopen.bmj.com/content/15/7/e087863.full |
| spellingShingle | Xiang Li Yong Yang Lingjia Yu Haining Tan Yuquan Liu Guangpeng Li Yuanshun Lo Zhu Bin Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocol BMJ Open |
| title | Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocol |
| title_full | Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocol |
| title_fullStr | Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocol |
| title_full_unstemmed | Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocol |
| title_short | Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocol |
| title_sort | percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis a single centre prospective non randomised cohort trial protocol |
| url | https://bmjopen.bmj.com/content/15/7/e087863.full |
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