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Comparing two surgical techniques for treating severe narrowing of the lower spine

A multi-center, prospective, randomized, comparative study comparing Oblique lumbar interbody fusion (OLIF) supplemented with lateral vertebral screw fixation versus transforaminal lumbar interbody fusion (TLIF) for the treatment of severe lumbar spinal stenosis (Schizas C, D type)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73844142
Enrollment
224
Registered
2024-11-05
Start date
2018-11-01
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Surgical treatment of patients with severe lumbar canal stenosis Musculoskeletal Diseases

Interventions

The total duration of treatment and follow-up for all study arms: from November 2018 to September 2021,a total of 224 LSS patients rated as Schizas C?D grade meeting above criteria were enrolled in th

Sponsors

The first affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. LSS patients presenting with radicular symptom or neurogenic claudication, relieved by lying in bed rest, with or without low back pain 2. Disabling symptoms refractory to a minimum of 3 months of conservative treatment 3. Single-level (L2-L5) central canal, recess or neuroforamina stenosis estimated as Schizas C, D grade on radiologic imaging in consistent with clinical symptoms

Exclusion criteria

Exclusion criteria: 1. Failure of relief of symptom by lying in bed rest 2. Congenital stenosis, ossification of ligamentum flavum or PLL, bony lateral recess stenosis, arthrodesis of facet joint, disc sequestration, complete loss of disc height 3. High grade spondylolistheis(IIIo or more) 4. Abnormal anatomy(limited corridor between major vessel and psoas ,anatomical variation of greater vessel); 5. Previous operation of left abdomen; 6. Infection, tumor, and so on

Design outcomes

Primary

MeasureTime frame
1. Clinical outcome is evaluated by Oswestry disability index (ODI) and visual analogue scale (VAS) at baseline, 3, 6, 12, 24 m postoperatively 2. Radiological parameters include disc height(DH), fused segmental lordosis(FSL), lumbar lordosis (LL),cross-sectional area of the thecal sac(CSA),all of which are measured at baseline, 3, 6, 12, 24 m postoperatively 3. Interbody fusion rate(IFR) is measured using CT/X-ray at 6, 12, 24 m postoperatively.

Secondary

MeasureTime frame
Measured after surgery using patient records: 1. Operation time(min) 2. Blood loss(ml) 3. First ambulation time(d) 4. Length of hospital stay(d)

Countries

China

Contacts

Public ContactXuefeng;Yijie Li;Liu

;

lixuefeng@suda.edu.cn;liuyijie@suda.edu.cn+86 51267972285;+86 51267972285

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026