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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorThe Affiliated Hospital of Qingdao University

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

340 Participants
are divided into 2 treatment groups

Locations

This trial has no 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