Lumbar SpondylolisthesisNCT07028099
A Study on the Clinical Use of a New Expandable OLIF Cage With Posterior Bone Grafting in Lumbar Spine Surgery
A study testing Expandable OLIF cage with posterior bone grafting and Conventional OLIF cage in people with Lumbar Spondylolisthesis and Degenerative Lumbar Scoliosis, run by The Affiliated Hospital of Qingdao University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lumbar Spondylolisthesis, Degenerative Lumbar Scoliosis, Lumbar Disc Herniation
- What is being tested?
- Expandable OLIF cage with posterior bone grafting and Conventional OLIF cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multi-Center Randomized Controlled Clinical Study on the Application of a Novel Expandable Posterior Bone Grafting OLIF Cage
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.
Read more
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
- Being tested
- Expandable OLIF cage with posterior bone grafting, Conventional OLIF cage
- Keywords
- Expandable OLIF Cage, Minimally Invasive Spine Surgery, Prospective Multicenter Randomized Controlled Trial, Degenerative Lumbar Disease
- Medical subject headings
- Spondylolisthesis, Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expandable OLIF cage with posterior bone graftingDevice
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.
Conventional OLIF cageDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Device: Conventional OLIF cage |
| Experimental group | Experimental | Not described Receives: Device: Expandable OLIF cage with posterior bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From enrollment to the 12th month after operation
Secondary outcomes (5)
Intervertebral Height
On lateral X-ray or CT images, the target intervertebral space is selected, and the intervertebral space heights of the leading edge, middle point and trailing edge are measured respectively, and the average value is taken to represent the intervertebral height of this segment.
Measured: From enrollment to the 12th month after operation
Clinical efficacy index of patients: VAS
Visual Analog Scale, (VAS) of pain. Measurement method: Patients were evaluated by VAS score before operation, 3 months, 6 months and 12 months after operation. Use a horizontal scale of 10 cm, with one end marked as "0 = painless" and the other end marked as "10 = the most severe pain". The patient draws a line on the ruler according to his own feelings, and measures the distance (in centimeters) from the starting point of "0" to the drawing point as the scoring result..
Measured: From enrollment to the 12th month after operation
Cobb angle of lumbar coronal plane
Used to evaluate lumbar scoliosis or coronal imbalance. Measurements are performed on preoperative and postoperative standing anteroposterior (AP) lumbar spine radiographs or coronal CT reconstructions. Identify the most tilted upper end vertebra and the most tilted lower end vertebra in the coronal plane; Draw lines along the upper endplate of the upper vertebra and the lower endplate of the lower vertebra; Construct perpendicular lines to each endplate line; The angle between these two perpendiculars is recorded as the coronal Cobb angle. The angle is recorded in degrees (°).
Measured: From enrollment to the 12th month after operation
Cobb angle of lumbar deformity surface
Draw lines along the superior endplate of L1 and the superior endplate of S1; The angle formed between these two lines is defined as the sagittal Cobb angle (lumbar lordosis angle). The angle is recorded in degrees (°).
Measured: From enrollment to the 12th month after operation
Clinical efficacy index of patients: ODI
Oswestry Disability Index, (ODI). Measurement method: The Chinese version of ODI scale was used, which was completed by patients' self-evaluation, including 10 items (such as pain intensity, personal care, walking, social life, etc.), and each item was scored at 5 levels. The total score is 50 points.In this study, a lower ODI score postoperatively reflects better functional recovery and greater treatment effectiveness.
Measured: From enrollment to the 12th month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start10 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Peking University People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Jinan Hospital, Xuanwu Hospital, Capital Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanghai Changzheng Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028099
- Sponsor's protocol ID
- QYFYEC2025-62
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) underlying the results of this study will be available upon reasonable request from qualified researchers. Access will be granted after the approval of a data-sharing agreement and ethical clearance. De-identified datasets will be provided to ensure patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Randomized Controlled Clinical Study on the Application of a Novel Expandable Posterior Bone Grafting OLIF Cage
- ClinicalTrials.gov ID
- NCT07028099
- Acronym / sponsor ID
- QYFYEC2025-62
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Peking University People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Jinan Hospital, Xuanwu Hospital, Capital Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanghai Changzheng Hospital
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Conventional OLIF cage |
| Experimental group | Experimental | Device: Expandable OLIF cage with posterior bone grafting |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expandable OLIF cage with posterior bone graftingThis 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. | Device | Experimental group |
| Conventional OLIF cageParticipants 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. | Device | Control group |
Primary outcome
Postoperative cage subsidence
Time frame: From enrollment to the 12th month after operation
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
ntraoperative cartilage endplate injury
Time frame: From enrollment to the 12th month after operation
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) underlying the results of this study will be available upon reasonable request from qualified researchers. Access will be granted after the approval of a data-sharing agreement and ethical clearance. De-identified datasets will be provided to ensure patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Expandable OLIF cage with posterior bone grafting and Conventional OLIF cage in people with Lumbar Spondylolisthesis and Degenerative Lumbar Scoliosis, run by The Affiliated Hospital of Qingdao University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuexiao XX Ma (+86 18661807895, maxuexiao7895@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cage subsidence (time frame: From enrollment to the 12th month after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.