Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery

NCT ID: NCT04946487

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-30

Brief Summary

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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)

Detailed Description

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Purpose: 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).

Methods: This retrospective study was performed in patients who received L5/S1 PLIF with pedicle screw instrumentation for lumbar spinal stenosis with or without isthmic spondylolisthesis. They were divided into the total laminectomy group, which had destruction of the PLC of the adjacent segment, or partial laminectomy group, which did not. Vertebral slip, osteophytes, disk height, and range of motion were examined by plain radiography, and thickness of the ligamentum flavum (LF) and anteroposterior diameters of the lumbar vertebral body and spinal canal were assessed by magnetic resonance imaging (MRI). Disc degeneration and spinal stenosis on MRI scans were categorized. The incidence of ASD and clinical outcome were compared between the groups.

Conditions

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Lumbar Spinal Stenosis

Keywords

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Adjacent Segment Degeneration lumbar posterior ligamentous complex posterior lumbar interbody fusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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group 1

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

total laminectomy

Intervention Type PROCEDURE

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

group 2

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

No interventions assigned to this group

Interventions

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total laminectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* previous spine surgery, acute spinal fracture, infection, and tumor.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weishi Li

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Central Contacts

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Zhuofu Li

Role: CONTACT

Phone: 15620610715

Email: [email protected]

Other Identifiers

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M2019232

Identifier Type: -

Identifier Source: org_study_id