Biportal endoscopic versus microscopic discectomy for lumbar herniated disc: a randomized controlled trial

被引:28
|
作者
Park, Sang-Min [1 ,2 ,3 ]
Lee, Ho-Jin [4 ]
Park, Hyun-Jin [5 ]
Choi, Jun -Young [1 ,2 ,3 ]
Kwon, Ohsang [1 ,2 ,3 ]
Lee, Sanghoon [1 ,2 ,3 ]
Kim, Ho-Joong [1 ,2 ,3 ,6 ,7 ,8 ]
Yeom, Jin S. [1 ,2 ,3 ]
机构
[1] Seoul Natl Univ, Coll Med, Spine Ctr, Seongnam, South Korea
[2] Seoul Natl Univ, Coll Med, Dept Orthoped Surg, Seongnam, South Korea
[3] Seoul Natl Univ, Bundang Hosp, Seongnam, South Korea
[4] Chungnam Natl Univ, Sch Med, Dept Orthopaed Surg, Daejeon, South Korea
[5] Hallym Univ, Kangnam Sacred Heart Hosp, Coll Med, Spine Ctr,Dept Orthoped Surg, Seoul, South Korea
[6] Seoul Natl Univ, Coll Med, Spine Ctr, 82 Gumi ro 173 Beon gil, Seongnam Si 13620, Gyeonggi Do, South Korea
[7] Seoul Natl Univ, Coll Med, Dept Orthoped Surg, 82 Gumi ro 173 Beon gil, Seongnam Si 13620, Gyeonggi Do, South Korea
[8] Seoul Natl Univ, Bundang Hosp, 82 Gumi ro 173 Beon gil, Seongnam Si 13620, Gyeonggi Do, South Korea
来源
SPINE JOURNAL | 2023年 / 23卷 / 01期
关键词
SPINE SURGERY; LEARNING-CURVE; QUESTIONNAIRE;
D O I
10.1016/j.spinee.2022.09.003
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
BACKGROUND CONTEXT: Biportal endoscopic discectomy has been frequently performed in recent years and has shown acceptable clinical outcomes. However, evidence regarding its efficacy and safety remains limited. PURPOSE: This study aimed to compare the clinical efficacy and safety of biportal endoscopic with that of open microscopic discectomy in patients with single-level herniated lumbar discs. STUDY DESIGN: Prospective, randomized, multicenter, open-label, assessor-blind, non-inferior-ity controlled trial. PATIENT SAMPLE: Sixty-four participants suffering from low back and leg pain with a single-level herniated lumbar disc and required discectomy. OUTCOME MEASURES: Outcomes were assessed with the use of patient-reported outcome measures (PROMs), visual analog scale (VAS) pain score for surgical site, low back and lower extremity, Oswestry Disability Index (ODI) for lumbar disabilities, European Quality of Life-5 Dimensions value for quality of life, and painDETECT for neuropathic pain. Surgery-related out-comes such as hospital stay, operation time, and opioid usage were collected. Adverse events occurring during the follow-up period were also noted. METHODS: All participants were randomly assigned in a 1:1 ratio to undergo biportal endoscopic (biportal group) or microscopic discectomy (microscopy group). The primary outcome was the dif-ference in ODI scores at 12-months post surgically based on a modified intention-to-treat strategy, with a non-inferiority margin of 12.8 points. The secondary outcomes included PROMs, surgery-related outcomes, and adverse events. RESULTS: The ODI score at the 12-month follow-up was 11.97 in the microscopy group and 13.89 in the biportal group (mean difference, 1.92; 95% confidence interval [CI],-3.50 to 7.34), showing the non-inferi-ority of biportal group. The results for the secondary outcomes were similar to those for the primary out-come. Creatinine phosphokinase ratios were low in the biportal group. Early surgical site pain was slightly lower in the biportal group (mean difference of VAS pain score at 48-hr,-0.98; 95% CI,-1.77 to -0.19). Adverse events including reoperation showed no significant difference between the groups.
引用
收藏
页码:18 / 26
页数:9
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