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

NCT07028099 | Not Yet Recruiting DMC

• 1 other identifier: QYFYEC2025-62
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Expandable OLIF Cage; Minimally Invasive Spine Surgery; Prospective Multicenter Randomized Controlled Trial; Degenerative Lumbar Disease

Outcome Measures

Primary Outcomes (2)

• Postoperative cage subsidence

  Radiological follow-up will be conducted immediately after surgery, and at 6, 12 months postoperatively using X-ray and/or CT imaging. Cage subsidence is defined as: ≥2 mm of cage penetration into the adjacent vertebral endplate compared to immediate postoperative imaging; Visible collapse of the cage-endplate interface; ≥10% reduction in intervertebral height compared to initial postoperative height. All radiographic assessments will be performed independently by two spine surgeons or radiologists blinded to group allocation. In case of discrepancy, a third reviewer will adjudicat

  From enrollment to the 12th month after operation

• ntraoperative cartilage endplate injury

  Endplate injury will be assessed intraoperatively by the operating surgeon through direct visual inspection and intraoperative fluoroscopy. Injury is defined as any of the following: Visible collapse, fracture, or tearing of the cartilaginous endplate during cage insertion; Evidence of asymmetric or excessive endplate compression on fluoroscopy; Explicit documentation of "endplate injury" or "endplate violation" in the operative record. Injury will be recorded in binary form (Yes/No). When necessary, postoperative CT scans may be used to confirm suspected endplate damage.

  From enrollment to the 12th month after operation

Secondary Outcomes (5)

• Intervertebral Height

  From enrollment to the 12th month after operation

• Clinical efficacy index of patients: VAS

  From enrollment to the 12th month after operation

• Cobb angle of lumbar coronal plane

  From enrollment to the 12th month after operation

• Cobb angle of lumbar deformity surface

  From enrollment to the 12th month after operation

• Clinical efficacy index of patients: ODI

  From enrollment to the 12th month after operation

Study Arms (2)

Control group

ACTIVE COMPARATOR

Device: Conventional OLIF cage

Experimental group

EXPERIMENTAL

Device: Expandable OLIF cage with posterior bone grafting

Interventions

Expandable OLIF cage with posterior bone grafting DEVICE

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 cages with fixed heights.

Experimental group

Conventional OLIF cage DEVICE

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 OLIF surgical protocols without additional design modifications.

Control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Clinically diagnosed with lumbar spondylolisthesis or lumbar spinal stenosis
• : Confirmed single-level lumbar degenerative disease
• : Affected level located at L2/3, L3/4, or L4/5
• : Failure of conservative treatment for at least 6 months

You may not qualify if:

• : History of prior lumbar or retroperitoneal surgery
• : Abnormal anatomy between the iliac vascular sheath and the psoas major muscle
• : Presence of active infection or other significant systemic diseases
• : Inability to complete surgical treatment or comply with follow-up due to various limitations

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• 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

MeSH Terms

Conditions

Spondylolisthesis; Intervertebral Disc Displacement; Spinal Stenosis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xuexiao XX Ma

CONTACT

+86 18661807895; maxuexiao7895@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 19, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share