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

NCT ID: NCT07028099

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-10
• Study Completion Date: 2027-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Group Type: ACTIVE_COMPARATOR

Conventional OLIF cage

Intervention Type: 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.

Experimental group

Group Type: EXPERIMENTAL

Expandable OLIF cage with posterior bone grafting

Intervention Type: 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.

Interventions

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 cages with fixed heights.

Intervention Type: 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 OLIF surgical protocols without additional design modifications.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

-

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role: collaborator

Jinan Hospital, Xuanwu Hospital, Capital Medical University

UNKNOWN

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Shanghai changzheng hospital, Naval Medical University

UNKNOWN

Sponsor Role: collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xuexiao XX Ma

Role: CONTACT

maxuexiao7895@163.com

+86 18661807895

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

QYFYEC2025-62

Identifier Type: -

Identifier Source: org_study_id