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Modified Mini-Open TLIF Versus Traditional Open TLIF for Lumbar Spinal Stenosis : A Prospective, Randomized Controlled Trial

Modified Mini-Open TLIF Versus Traditional Open TLIF for Lumbar Spinal Stenosis : A Prospective, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112527
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Lumbar spinal stenosis

Interventions

mMO-TLIF surgery group:Modified Mini-Open Transforminal Lumbar Interbody Fusion
Traditional TLIF surgery group:The traditional Open Transforminal Lumbar Interbody Fusion

Sponsors

The First People's Hospital of Lianyungang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Eligible patients are aged between 18 and 80. 2. There is unilateral neurogenic claudication or radicular pain in the lower extremities, and there is no response to at least 3 months of conservative treatment; 3. There is bilateral neurogenic claudication or radicular pain in the lower extremities, but the neurological symptoms of at least one lower extremity completely subside during the supine position, and the physical examination is not obvious, and there is no response to at least 3 months of conservative treatment; 4. The patient must have imaging evidence of stage 1-2 lumbar spinal stenosis confirmed by magnetic resonance imaging (MRI), and it must be confirmed on the standing lateral X-ray that there is only evidence of instability in the stenotic segment. 5. MMO-TLIF or TLIF surgical treatment was performed by the same physician in each observation hospital; 6. The observed subjects voluntarily participated and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.There is bilateral radicular pain in the lower extremities, which does not completely subside at rest. 2. Previous history of lumbar trauma or surgery. 3. There is a spinal infection, tuberculosis or tumor. 4. Surgical contraindications, such as severe systemic diseases, coagulation disorders, severe active infectious diseases or osteoporosis. 5. Obvious intervertebral space collapse, with bony ankylosis, etc. 6. Incomplete data.

Design outcomes

Primary

MeasureTime frame
Oswestry Disability Index (ODI);

Secondary

MeasureTime frame
Pain VAS scores;Zurich Claudication Questionnaire (ZCQ) score;Brock Quality of Life Five Dimensions (EQ-5D-3L) questionnaire score;Operative Time;Intraoperative Blood Loss;Transfusion Rate;Time to Ambulation ;Length of Hospital Stay;Incidence of complications;Radiographic fusion rate;

Countries

China

Contacts

Public ContactLv You

The First People's Hospital of Lianyungang

gwykr@outlook.com+86 518 8576 7007

Outcome results

None listed

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