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

Qingdao University

Status: Not yet enrolling

Conditions: Lumbar Spinal Stenosis; Lumbar Spondylolisthesis; Lumbar Disc Herniation; Degenerative Lumbar Scoliosis

Treatments: Device: Expandable OLIF cage with posterior bone grafting; Device: Conventional OLIF cage

Study type: Interventional

Funder types: Other

Identifiers

NCT07028099

QYFYEC2025-62

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:1: Age between 40 and 80 years (inclusive)

2: Clinically diagnosed with lumbar spondylolisthesis or lumbar spinal stenosis

3: Confirmed single-level lumbar degenerative disease

4: Affected level located at L2/3, L3/4, or L4/5

5: Failure of conservative treatment for at least 6 months

Exclusion Criteria:1: Patients requiring direct decompression of the spinal canal

2: History of prior lumbar or retroperitoneal surgery

3: Abnormal anatomy between the iliac vascular sheath and the psoas major muscle

4: Presence of active infection or other significant systemic diseases

5: Inability to complete surgical treatment or comply with follow-up due to various limitations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Control group

Active Comparator group

Treatment:

Device: Conventional OLIF cage

Experimental group

Experimental group

Treatment:

Device: Expandable OLIF cage with posterior bone grafting