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A prospective comparative study of three internal fixation methods in single-level MIS-TLIF

A prospective comparative study of three internal fixation methods in single-level MIS-TLIF

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072041
Enrollment
Unknown
Registered
2023-06-01
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

lumbar degenerative disease

Interventions

BPSF group:bilateral pedicle screw fixation
UPSF group:unilateral pedicle screw fixation
UPSFS group:unilateral pedicle screws plus contra-lateral translaminar facet screws fixation

Sponsors

The Third Affiliated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The age range is 30-70 years old. 2. Patients with chronic low back pain or unilateral radicular symptoms in a single lower limb, who had been underwent at least 3 months of fail conservative therapies. 3. The patient's preoperative VAS score for back pain or leg pain should be =4 points for at least one item. 4. The following imaging features are met: Single-level lesions of the low lumbar spine consistent with the symptoms and signs, typical unilateral lumbar disc herniation or lumbar instability, lumbar spinal stenosis, lumbar spondylolisthesis (Meyerding Grade I), facet joint Weishaupt = Grade II, paravertebral muscle Goutallier = Grade III. 5. The patient agreed and voluntarily signed informed consent forms and were able to comply with study protocols and visit plans.

Exclusion criteria

Exclusion criteria: 1.Multisegmental lesions of lumbar spine. 2.Subjects were eligible for any of the following: Severe lumbar spine trauma in the last 6 months, complicated with spinal infection, tuberculosis, tumors, spinal fracture or deformity. Lumbar spondylolisthesis with degree II or above, or lumbar spondylolysis. Hypoplasia of pedicle, lamina or facet, spondylolysis, severe lumbar spinal stenosis requiring removal of most facet decompression or extensive bilateral fenestration. 3.Patients with severe osteoporosis (T-score =-2.5) or obesity (BMI =25 kg/m2). 4.SDS=63 points or SAS=60 points. 5.Patients during pregnancy and lactation. 6. Patients with severe underlying diseases or mental disorders who can not tolerate surgery. 7. A person known to have a disease that the investigator considers an impediment to entry into the study. 8. Those who could not comply with the study assessment or complete the questionnaire for various reasons.

Design outcomes

Primary

MeasureTime frame
fusion rate;Radiological measurements;

Secondary

MeasureTime frame
visual analogue scale(VAS);Oswestry Disability Index(ODI);EQ-5D;SF-36;operation time;intraoperative blood loss;postoperative drainage;postoperative hospital stay;complications;

Countries

China

Contacts

Public ContactQingchu Li

The Third Affiliated Hospital of Southern Medical University

lqc16@263.net+86 186 8022 5370

Outcome results

None listed

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