Abstract: BACKGROUND: 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 and outcomes of transforaminal endoscopy on lumbar disc herniation in human immunodeficiency virus-infected patients are poorly understood.   
OBJECTIVE: To observe the curative effect and prognosis of lumbar disc herniation patients with human immunodeficiency virus infection treated by transforaminal endoscopy. 
METHODS: This is a prospective, single-center, non-randomized, controlled, 2-year follow-up clinical study. Sixty human immunodeficiency virus-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 trial 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. 
RESULTS AND CONCLUSION: (1) The primary outcome measure of this study is the symptom improvement rate evaluated by the Japanese Orthopedic Association score at 24 months after the surgery. (2) The secondary outcome measures include 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 Score, 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. (3) In our preliminary study ongoing between January 2016 and January 2018, 86 patients were included and divided into two groups, i.e. the trial 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 trial and control groups, and no adverse reactions occurred. However, the improvement rate of the Visual Analogue Scale Score in the trial group was higher than that in the control group (P < 0.05). (4) The results of this study can be used to indicate whether transforaminal endoscopy with minimal trauma in the treatment of lumbar disc herniation in human immunodeficiency virus-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 human immunodeficiency virus-infected patients with lumbar disc herniation. This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2000037464) on August 28, 2020. Protocol version (1.0). 

Key words: bone, lumbar spine, intervertebral disc, transforaminal endoscopy, human immunodeficiency virus, pain, non-randomized controlled clinical trials, tissue engineering