Skip to content

Comparison of pedicle screw-plate system and pedicle screw-rod system in minimally invasive lumber transforaminal interbody fusion: a prospective, randomized, non-inferiority trial.

Comparison of pedicle screw-plate system and pedicle screw-rod system in minimally invasive lumber transforaminal interbody fusion: a prospective, randomized, non-inferiority trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002863
Enrollment
Unknown
Registered
2012-12-24
Start date
2013-01-15
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

Symptomatic 1, 2 grade spondylolisthesis, recurrent prolapse disc , discogenic low back pain, spinal stenosis, The conservative treatment of radicular pain more than six months.

Interventions

test group:Useing Zola pedicle screw-plate system for MIS-TLIF
control group:Useing Sextant pedicle screw-rod system for MIS-TLIF

Sponsors

Department of Orthopedics, Xinqiao Hospital, The Third Military Medical University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patient age range 18 to 75; 2) The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial; 3) Surgery is one-level minimally invasive lumber transforaminal interbody fusion; 4) Agree to use the minimally invasive Zola pedicle screw-plate system or Sextant pedicle screw-rod system for surgery; 5) No significant heart, lung, liver and kidney dysfunction, can tolerate surgery.

Exclusion criteria

Exclusion criteria: 1) Patients with spinal implants placed; 2) Spinal infection; 3) Acute spinal injury; 4) Patients with malignant or expected survival time of patients less than 12 months; 5) Patient with severe spinal deformity.

Design outcomes

Primary

MeasureTime frame
The incidence of 12 months with Bridwell bone fusion rate;

Secondary

MeasureTime frame
The incidence of 12 months without major equipment;

Countries

China

Contacts

Public ContactZhou Yue
Happyzhou@vip.163.com+86 13908390792

Outcome results

None listed

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