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Minimally invasive decompression alone versus minimally invasive transforaminal lumbar interbody fusion for stable lumbar grade I degenerative spondylolisthesis: a multicenter, open-label, randomized, controlled trial

Minimally invasive decompression alone versus minimally invasive transforaminal lumbar interbody fusion for stable lumbar grade I degenerative spondylolisthesis: a multicenter, open-label, randomized, controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055182
Enrollment
Unknown
Registered
2022-01-02
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Stable first-degree degenerative lumbar spondylolisthesis

Interventions

Control group:Intervertebral discectomy through transforaminal approach under the tunnel + intervertebral bone graft fusion and internal fixation (MIS-TLIF)
Experimental group:Simple laminectomy decompression under the tunnel (Minimally invasive decompression alone)

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Stable first-degree degenerative spondylolisthesis: (1) The forward sliding of the vertebral body does not exceed 1/4 of the mid-sagittal diameter of the vertebral body; (2) The sagittal displacement of the dynamic X-ray spondylolisthesis is less than 3mm and the change of the intervertebral angle is less than 11 degree; (3) Not associated with spondylolisthesis; 2. There are symptoms such as lower limb radicular pain, numbness, fatigue, intermittent claudication with or without low back pain; 3. Conservative treatment is ineffective for half a year. 4. Age greater than 18 years and less than 80 years.

Exclusion criteria

Exclusion criteria: 1. Systemic or local active infection; 2. Malignant tumor: The patient has a clear history of malignant tumor (except non-malignant melanoma), unless the patient has received effective treatment and no clinical symptoms and signs have been found for at least 5 years; 3. Patients who have received lumbar spine surgery in the past; 4. Those who are unable to accept or tolerate surgery due to major organ disease or other reasons, or ASA (American Society of Anesthesiologists) grade IV or above; 5. Patients with abnormal mental and social psychological functions; 6. Refused to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Oswestery Disability Index;

Secondary

MeasureTime frame
SF-36 Quality of Life Score;Surgery related conditions;Clinical function evaluation;Imaging evaluation;Low back muscle function evaluation;

Countries

China

Contacts

Public ContactWei Fuxin

The Seventh Affiliated Hospital of Sun Yat-sen University

weifuxin@mail.sysu.edu.cn+86 13560170686

Outcome results

None listed

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