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Background and objective: Transforaminal endoscopy has certain advantages over traditional surgeries (e.g., intervertebral disc fusion) in the treatment of lumbar disc herniation, as it is associated with minimal trauma, clear surgical vision, and lower degree of bleeding. However, the therapeutic effects of transforaminal endoscopy on lumbar disc herniation in human immunodeficiency virus (HIV)-infected patients are poorly understood. The purposes of this study are to indicate the efficacy of transforaminal endoscopy in the treatment of lumber disc herniation in HIV-infected patients and compare the efficacy between transforaminal endoscopy and conventional lumbar disc fusion based on 2-year follow-up and prognosis turnover. Subjects and Methods: This is a prospective, single-center, non-randomized, controlled, 2-year follow-up clinical study. Sixty HIV-infected patients with lumbar disc herniation who will receive treatment in the Shanghai Public Health Clinical Center will be included in this study. These patients will be divided into two groups according to the surgical treatment. Patients in the experimental group (n = 30) will undergo nucleus pulposus enucleation under an intervertebral foramen endoscope, while patients in the control group (n = 30) will undergo intervertebral disc fusion. All patients will be followed up postoperatively at 6, 12, and 24 months. This study was approved by the Institutional Ethics Committee of Shanghai Public Health Clinical Center of China (approval No. [2020]2020-S122-02) on July 28, 2020. All participants will be informed about the study protocol and will be asked to provide written informed consent. This study was designed on November 30, 2018. Patient recruitment will be performed in the period between October 30, 2020 and April 30, 2021. The study outcomes will be analyzed between May 1, 2023 and May 30, 2023. The study will be terminated on June 30, 2023. The primary outcome measure of this study is the change in the symptom improvement rate evaluated by the Japanese Orthopedic Association score at 24 months after the surgery. The secondary outcome measures include the changes in the symptom improvement rate evaluated by the Japanese Orthopedic Association score at 6 and 12 months after the surgery; pain improvement rate evaluated by the Visual Analogue Scale, and improvement in the quality of life evaluated by 36-Item Short Form Health Survey (SF-36) at 6, 12, and 24 months, as well as the recurrence rate of lumbar disc herniation and the incidence of postoperative adverse reactions at 6, 12, and 24 months after the surgery. Results: In our preliminary study ongoing between January 2016 and January 2018, 86 patients were included and divided into two groups, i.e., the experimental group (n = 48; nucleus pulposus enucleation under intervertebral foramen endoscope) and the control group (n = 38; intervertebral disc fusion). Six-month follow-up results revealed that the mortality of the experimental and control groups was 0 during and 6 months after the surgery, and no deaths occurred due to intervertebral foramen endoscope surgery or postoperative adverse reactions. Six-month follow-up results revealed that the improvement rate of the Japanese Orthopedic Association score and recurrence rate were comparable between the experimental and control groups, and no adverse reactions occurred. However, the improvement rate of the Visual Analogue Scale in the experimental group was higher than that in the control group (P Conclusion: The results of this study can be used to indicate whether transforaminal endoscopy with minimal trauma in the treatment of lumbar disc herniation in HIV-infected patients is associated with better medium- and long-term surgical effects and prognosis as well as turnover than intervertebral disc fusion. The innovation of this study lies in a fact that the subjects are HIV-infected patients with lumbar disc herniation. Trial registration: This study was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2000037464) on August 28, 2020. Study protocol: 1.0. |
