Clinical trial to confirm the effectiveness and safety of pedicle screw products used in spinal fusion for patients with spinal diseases

A single-center, open-label, exploratory clinical trial to evaluate the efficacy and safety of pedicle screw devices in patients with spinal disorders

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010501

Enrollment

Registered

2025-05-22

Start date

2025-05-22

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

None listed

Interventions

Medical Device : The test group is a study that uses medical devices available domestically during intervertebral fusion surgery under routine care, and the treatment and management process is the sam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 80 years old 2) Patients with spinal diseases requiring surgery due to lumbar disc, lumbar spinal stenosis, spondylolisthesis, or spondylolisthesis 3) Those requiring level 1 or level 2 surgery 4) Those aged 70 or older with a K-MMSE score of 24 or higher 5) Those who fully understand the purpose and procedure of the trial and wish to participate in the clinical trial through voluntary consent

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women, or women of childbearing age who have not agreed to maintain contraception during the clinical period 2) Patients undergoing spinal instrumentation after spinal or intervertebral disc infection or removal of vertebral body and spinal cord tumors 3) Patients who have previously undergone lumbar interbody fusion 4) Patients with mental or neuromuscular disorders that may result in unacceptable risks of fixation failure or postoperative complications 5) Those with a BMI of 25 or higher 6) Those with bone deformities that may interfere with the safety of screw fixation 7) Those with open wounds 8) Those with reported or suspected metal sensitivity 9) Patients with inadequate body tissue covering the surgical site 10) Those deemed unsuitable for clinical study participation by the investigator for other reasons 11) Those currently participating in another clinical trial or those who participated in another clinical trial within 1 month prior to enrollment in this clinical trial

Design outcomes

Primary

Measure	Time frame
Visual Analog Scale	—

Secondary

Measure	Time frame
Radiological examination (X-ray): Pedicle screw pull-out, Pedicle screw migration, rod breakage, Screw nut pull-out;Blood test (ESR/CRP);Oswestry disability index;Radiological examination (CT)	—

Countries

Korea, Republic of

Contacts

Public ContactSEUNG-ROK KANG

Jeonbuk National University Hospital

srkang@mdctc.or.kr+82-63-259-3458

Outcome results