About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
None
Trial design
Treatments tested in this trial
- Expandable OLIF cage with posterior bone grafting
- Conventional OLIF cage
Treatment groups
Locations
Sponsors and collaborators
The Affiliated Hospital of Qingdao University
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
Peking University People's Hospital
Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator
Jinan Hospital, Xuanwu Hospital, Capital Medical University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Shanghai changzheng hospital, Naval Medical University
Collaborator