A Study on the Clinical Use of a New Expandable OLIF Cage With Posterior Bone Grafting in Lumbar Spine Surgery

This clinical trial aims to evaluate the safety and effectiveness of a novel expandable OLIF (Oblique Lateral Interbody Fusion) cage with posterior bone grafting in patients with lumbar degenerative diseases. OLIF is a minimally invasive spinal surgery technique that restores intervertebral height and relieves nerve compression by placing a cage into the disc space. The new device allows surgeons to adjust the height of the cage during surgery and deliver bone grafts through a special channel after expansion. This study compares the outcomes of patients receiving the new cage versus those treated with a conventional OLIF cage. The trial will assess pain relief, functional improvement, spinal stability, fusion success, and potential complications. Radiological images and patient-reported scores (like VAS and ODI) will be collected over 12 months. The study includes patients aged 40 to 80 with single-level lumbar spine disease who have not improved after at least 6 months of conservative treatment. This study will help determine whether the new expandable cage offers clinical advantages and better long-term outcomes for patients undergoing OLIF surgery.

NCT Number	NCT07028099
Lead Sponsor	The Affiliated Hospital of Qingdao University Collaborators: The First Affiliated Hospital of Zhengzhou University, Peking University People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Jinan Hospital, Xuanwu Hospital, Capital Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanghai changzheng hospital, Naval Medical University
Conditions	Lumbar Spondylolisthesis, Degenerative Lumbar Scoliosis, Lumbar Disc Herniation, Lumbar Spinal Stenosis
Enrollment	340 participants
Start Date	2025-06-10
Primary Completion	2026-06-01 (estimated)
Study Completion	2027-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-19