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A cohort study of hierarchical OLIF clinical protocol based on high inducible osteogenic activity materials

A cohort study of hierarchical OLIF clinical protocol based on high inducible osteogenic activity materials

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074810
Enrollment
Unknown
Registered
2023-08-16
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative diseases of the lumbar spine

Interventions

Innovative path group:Allogeneic decalcified bone matrix (DBM, Beijing Xinkangchen Medical Technology Development Co.) + rhBMP-2 (BMP, Hangzhou jiuyuan gene engineering co .,ltd.) + anatomical interve
Traditional path domestic fuser group:The anterolateral lumbar interbody fusion surgery was performed with anatomical intervertebral fusion (Shanghai Sanyou Medical Devices Co.), and the key techniqu
Traditional path import fuser group:The anterolateral lumbar interbody fusion surgery was performed with imported intervertebral fusion device, and the key techniques of the innovative path in this p

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 40-80 years old; 2. There are clinical symptoms of lumbar spinal stenosis, such as neurogenic claudication or radiating pain in the lower extremities, and conservative treatment is ineffective for more than 3 months of lumbar degenerative diseases: including lumbar spinal stenosis, lumbar degenerative slippage and degenerative scoliosis deformity; 3. Imaging manifestations corresponding to the clinical symptoms of lumbar spinal stenosis, including central canal stenosis (Schizas grade B and C) or intervertebral foramen stenosis (Lee grade 2 and 3), lumbar degenerative slip (Meyerding grade I and II), lumbar degenerative scoliosis deformity (Lenke-Silva grade I-III). 4. Sign the informed consent form, agree to enter the research cohort, and ensure follow-up.

Exclusion criteria

Exclusion criteria: 1. Severe lumbar spinal stenosis (Schizas grade D for central canal stenosis or Lee grade 4 for foraminal stenosis); 2. Severe lumbar degenerative slippage (Meyerding grade III or above); 3. Severe lumbar degenerative scoliosis deformity (Lenke-Silva grade IV or above); 4. Previous history of lumbar spine or abdominal surgery; 5. Lumbar facet joint fusion; 6. Lumbar segment blocked by ribs (thoracic segment) or iliacium; 7. Bone mineral density T value (DXA method) =-3.5; 8. BMI =30; 9. Combined with epilepsy, Parkinson's disease and other internal medical diseases; 10. Inability to sign informed consent form or inability to sign informed consent form.

Design outcomes

Primary

MeasureTime frame
Lumbar spine fusion rate;

Secondary

MeasureTime frame
Postoperative functional score;

Countries

China

Contacts

Public ContactSun Tiansheng

Chinese PLA General Hospital

suntiansheng-@163.com+86 10 8400 8001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026