NCT04946487

Brief Summary

To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

June 27, 2021

Last Update Submit

June 27, 2021

Conditions

Lumbar Spinal Stenosis

Keywords

Adjacent Segment Degenerationlumbar posterior ligamentous complexposterior lumbar interbody fusion

Outcome Measures

Primary Outcomes (1)

  • the Incidences of adjacent segment degeneration

    the Incidences of adjacent segment degeneration

    From the end of treatment to more than 8 years

Study Arms (2)

group 1

patients in this group destructed the posterior ligamentous complex of the adjacent segment

Procedure: total laminectomy

group 2

patients in this group did not destruct the of the posterior ligamentous complex of the adjacent segment

Interventions

total laminectomyPROCEDURE

Total laminectomy removes the posterior ligamentous complex (PLC) at the fusion and superior levels.

group 1

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From January 2010 to December 2014

You may qualify if:

  • typical clinical symptoms such as disabling low back or leg pain with or without neurological symptoms, intermittent claudication, with refractory to ≥6 months of strict conservative treatment; and L5/S1 single-level PLIF with pedicle screw instrumentation.

You may not qualify if:

  • previous spine surgery, acute spinal fracture, infection, and tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Weishi Li

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuofu Li

CONTACT

15620610715840764209@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

June 30, 2021

Study Start

July 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share