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A multicenter, randomized, controlled study for different approaches of TLIF in the treatment of senile lumbar spinal stenosis

A multicenter, randomized, controlled study for different approaches of TLIF in the treatment of senile lumbar spinal stenosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029774
Enrollment
Unknown
Registered
2020-02-13
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

Senile lumbar spinal stenosis

Interventions

Group 1:Wiltse approach TILF surgery
Group 2:Mis-TLIF surgery
Group 3:Conventional approach TLIF

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Over 60 years old, regardless of gender; 2. Clearly diagnosed as lumbar spinal stenosis, but invalid or aggravated after strict formal conservative treatment, and TLIF surgery is required according to clinical guidelines and operation indication; 3. No previous lumbar surgery history due to lumbar diseases; 4. Patient fully understands the content and requirements of this clinical study, and be able to complete the corresponding follow-up in accordance with the schedule; 5. Volunteer to participate in clinical trials and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patient with systemic infection, or local infection, incurable malignant tumor at the target surgical site 2. Patient with neurological diseases or diseases that may affect clinical evaluation; 3. Patient with other non-degenerative lumbar diseases, such as lumbar spondylitis and ankylosing spondylitis; 4. Patient with a operation history of responsible vertebrea; 5. Patient has internal plant allergy, or the clinical taboo of pedicle screw fixation judged by researcher; 6. Patient with benign or malignant tumors, tuberculosis, infection and other diseases in the target vertebrae that affect clinical evaluation 7. Patient fails to follow doctor's advice and complete 2-year follow-up, or life expectancy less than 2 years due to various reasons; 8. Bibulosity within one year (mean daily > 40g, equivalent to 100ml of 50c liquor), smoking >= 40 cigarettes/day, or substance abuse; 9. Patient participating in other drugs or instruments clinical trial, and the effect of drugs and instruments on clinical efficacy cannot be determined. 10. Patient with other circumstances inappropriate to participate in this study considered by some researchers.

Design outcomes

Primary

MeasureTime frame
JOA;SF-36;VAS;

Secondary

MeasureTime frame
multifidus atrophy;fusion rate;

Countries

China

Contacts

Public ContactDianwen Song

Shanghai General Hospital

songdianwen@msn.com+86 13901692694

Outcome results

None listed

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