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Not yet recruiting NCT07028099

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

No phase Interventional Lumbar Spondylolisthesis Degenerative Lumbar Scoliosis Lumbar Disc Herniation Lumbar Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Expandable OLIF cage with posterior bone grafting, Conventional OLIF cage.
Who it may be relevant to
Registry conditions: Lumbar Spondylolisthesis, Degenerative Lumbar Scoliosis, Lumbar Disc Herniation, Lumbar Spinal Stenosis. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Multi-Center Randomized Controlled Clinical Study on the Application of a Novel Expandable Posterior Bone Grafting OLIF Cage

Overview

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.

Interventions

  • Device Expandable OLIF cage with posterior bone grafting
    This intervention involves the use of a novel expandable OLIF cage that allows intraoperative height adjustment and posterior bone grafting through a dedicated channel. The device is designed to restore intervertebral height and lumbar lordosis while minimizing endplate injury. Bone grafts (autologous or synthetic) are delivered after expansion to enhance fusion. This design aims to reduce cage subsidence, improve fusion rates, and simplify the surgical workflow compared to conventional OLIF cag
  • Device Conventional OLIF cage
    Participants in the control group will undergo oblique lateral interbody fusion (OLIF) using a standard non-expandable interbody fusion cage. The cage has a fixed height and is inserted via the retroperitoneal approach. Bone grafts are packed into the cage prior to insertion through the anterior or lateral window. This represents the current standard practice for OLIF procedures and does not allow intraoperative height adjustment or posterior graft delivery. The procedure follows conventional OL

Primary outcome measures

  • Postoperative cage subsidence [Time frame: From enrollment to the 12th month after operation]
  • ntraoperative cartilage endplate injury [Time frame: From enrollment to the 12th month after operation]
Secondary outcome measures (5)
  • Intervertebral Height [Time frame: From enrollment to the 12th month after operation]
  • Clinical efficacy index of patients: VAS [Time frame: From enrollment to the 12th month after operation]
  • Cobb angle of lumbar coronal plane [Time frame: From enrollment to the 12th month after operation]
  • Cobb angle of lumbar deformity surface [Time frame: From enrollment to the 12th month after operation]
  • Clinical efficacy index of patients: ODI [Time frame: From enrollment to the 12th month after operation]

Eligibility 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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07028099 · QYFYEC2025-62

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗