The clinical effect assessment of lumbar fusion and adjacent segment protection with lumbar fusion in the treatment of lumbar degenerative disease

The clinical effect assessment of single-level lumbar fusion and adjacent segment protection with lumbar fusion in the treatment of lumbar degenerative disease

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONRC-12002281

Enrollment

Unknown

Registered

2012-06-15

Start date

2012-07-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

lumbar degenerative disease

Interventions

A:Lesion segmental: lumbar fusion

B:Isobar and K-Rod and Dynesys

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years; 2. obvious clinical symptoms such as low back pain or numbness, decreased lower extremity muscle strength, Intermittent claudication, etc. Obviously affect daily life and work; 3. Radiographic evidence: Lumbar spinal stenosis, Lumbar spondylolisthesis?Lumbar spinal instability, Serious prolapse of lumbar intervertebral disc; 4. Patients who need second operation with recurrent disc herniation and adjacent level herniation; 5. Adjacent level degeneration (Mild instability, mobility >15 degree; Vertebral shift >3 mm; Edge bone spur formation; Black the disk, gap height declined, disc prolapse during or mild outstanding, etc); 6. Patients whose symptoms aren’t obviously improved with strict and standard conservative treatment more than 1 month.

Exclusion criteria

Exclusion criteria: 1. Patients who combine with other lumbar lesions such as lumbar spondylolisthesis, lumbar spondylolysis, spinal stenosis, discogenic low back pain, spinal organic deformity, spine fracture, ankylosing spondylitis, tuberculosis of spine, Spinal infection and spinal tumor, and cervical diseases. 2. Patients who have trauma and diseases of lower extremity joint, muscles and nervus which affect the function of lower extremity; 3. Osteoporosis patients (BMD<2.0s); 4. Patients who combine with trauma and diseases of nervous system; 5. Patients who combine with other systemic diseases; 6. Psychotic patients, Pregnant women or women planning to get pregnant during the study period, Has a history of substance abuse (recreational drugs, alcohol), Is currently involved in another study.

Design outcomes

Primary

Measure	Time frame
VAS score;ODI score;Macnab classification;ROM of lumbar;Recurrent disc herniation or no;	—

Secondary

Measure	Time frame
Woodend classification;operation time;blood loss during operation;hospitalization time;	—

Countries

China

Contacts

Public ContactQiang Zhou

zqtlh@yahoo.com.cn+86 13677669899

Outcome results

None listed

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