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Clinical Evaluation of Paraspinal Mini-Tubular Lumbar Decompression (PMTD) Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Spondylolisthesis with Lumbar Stenosis: a Randomised Controlled Trial

Clinical Evaluation of Paraspinal Mini-Tubular Lumbar Decompression (PMTD) Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Spondylolisthesis with Lumbar Stenosis: a Randomised Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047365
Enrollment
Unknown
Registered
2021-06-13
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-02-07

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

Conditions

Grade I spondylolisthesis with lumbar spinal stenosis

Interventions

PMTD Group:paraspinal mini-tubular lumbar decompression
MIS-TLIF Group:minimally invasive transforaminal lumbar interbody fusion

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Entry age: 30-75 years old; 2. There are obvious symptoms of intermittent claudication, which is ineffective after conservative treatment for 3 months; 3. I degree lumbar spondylolisthesis (according to Meyerding lumbar spondylolisthesis classification); 4. All patients have undergone MRI and CT to confirm lumbar spondylolisthesis and lumbar spinal stenosis, and the location of the stenosis is consistent with the corresponding neurological symptoms; 5. Lumbar spine X-ray film (lateral position, double oblique position, hyperextension and flexion position), no segmental lumbar instability (The preoperative X-ray film of the lateral position of hyperextension and flexion shows that the angle difference between the upper and lower endplates of the diseased segment is less than 10° or the distance between the vertebral bodies is less than 3mm); 6. The patient's informed consent.

Exclusion criteria

Exclusion criteria: 1. Surgery on the same segment or adjacent segments; 2. Pregnant or lactating women; 3. Patients with cauda equina syndrome; 4. The expected survival time is less than 1 year; 5. Other serious physical or mental illnesses are not suitable for surgery; 6. Those who are not suitable for special examinations such as MRI and CT enhancement.

Design outcomes

Primary

MeasureTime frame
short form-36 physical-component summary;

Secondary

MeasureTime frame
Japanese Orthopaedic Association low back pain score;visual analogue scale;Oswestry disability index;complications;blood loss;operative time;duration of hospital stay;

Countries

China

Contacts

Public ContactChen Chunmei
cmchen2009@sina.com+86 13509339040

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026