NCT04467944 Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery
| NCT ID | NCT04467944 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Degenerative Lumbar Spinal Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 210 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2022-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 210 participants in total. It began in 2018-01-01 with a primary completion date of 2022-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for lumbar degenerative disease are prospectively enrolled and followed. Important adjacent pre-existing degeneration factors include discs degenerated, facets and ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). This study will focus on the effects of pre- existing adjacent degeneration (disc factors and spinal canal stenosis factors) on long-term postoperative outcomes.
Eligibility Criteria
Inclusion Criteria: * A clear diagnosis of lumbar spinal stenosis, and surgical level of L4- S1 (The levels to be operated on were decided by matching the clinical symptomatology with the radiological findings of the spinal levels that needed decompression); * Failed at least eight weeks conservative treatment; Exclusion Criteria: * Unstable factors (slip, rotation, lateral bending, etc.) in adjacent segment L3/4; * Preoperative sagittal and coronal imbalance of the spine; * Lumbar infection and/or tumor diseases; * A previous history of lumbar fusion surgery.
Contact & Investigator
Wei Shi Li, Dr.
PRINCIPAL INVESTIGATOR
Peking University Third Hospital
Frequently Asked Questions
Who can join the NCT04467944 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Degenerative Lumbar Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04467944 currently recruiting?
Yes, NCT04467944 is actively recruiting participants. Contact the research team at puh3_szr@outlook.com for enrollment information.
Where is the NCT04467944 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04467944 clinical trial?
NCT04467944 is sponsored by Peking University Third Hospital. The principal investigator is Wei Shi Li, Dr. at Peking University Third Hospital. The trial plans to enroll 210 participants.