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The clinical comparative study of the novel technique of foraminoplasty by reciprocating high-speed drill and TESSYS foraminoplasty in the treatment of lumbar disc herniation

The clinical comparative study of the novel technique of foraminoplasty by reciprocating high-speed drill and TESSYS foraminoplasty in the treatment of lumbar disc herniation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049090
Enrollment
Unknown
Registered
2021-07-20
Start date
2021-07-05
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Lumbar Disc Herniation

Interventions

STAFF group:A novel reciprocating power-aided foraminoplasty
TESSYS group: Traditional TESSYS foraminoplasty

Sponsors

Spine Surgery Department of Orthopaedics Centre, Army Medical Center of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 50 years; 2.Single-segment lumbar disc herniation(L4/5), symptoms and signs of unilateral lumbar 5 nerve root compression; 3.CT/MRI examination accords with lumbar 4/5 disc herniation and compression of the unilateral lumbar 5 nerve roots; 4.Patients had received at least 6 months of conservative treatment that turned out to be ineffective.

Exclusion criteria

Exclusion criteria: 1. cauda equina syndrome; 2. Dynamic X-ray films suggest lumbar instability or spondylolisthesis; 3. Infectious diseases such as lumbar tuberculosis and tumors; 4. Other interventional treatments such as spinal surgery, radiofrequency ablation, ozone injection, etc. have been previously performed in this segment; 5. Severe cardiopulmonary disease or other patients who cannot tolerate surgery; 6. Those who are unwilling or unable to participate in treatment and postoperative follow-up.

Design outcomes

Primary

MeasureTime frame
Horizontal transverse diameter of superior articular process;Foraminoplasty time;Intraoperative decompression time;Operation time;X-ray exposure;OSWESTRY Disability Index;pain visual analogue scale;Modified MacNab Efficacy Evaluation;

Secondary

MeasureTime frame
Puncture time;Foraminoplasty pain;Surgical complications;

Countries

China

Contacts

Public ContactFan weili

Spine Surgery Department of Orthopaedics Centre, Army Medical Center of PLA

williemfan@163.com+86 13883916853

Outcome results

None listed

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