Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion

September 16, 2020 updated by: Peking University Third Hospital

Preventive Effect of Limited Decompression on Adjacent Segment With Pre-existing Spinal Canal Stenosis Following Posterior Lumbar Interbody Fusion: a Prospective Interventional Study

This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for degenerative disease are prospectively enrolled and followed. Patients enrolled in this study have asymptomatic pre-existing spinal canal stenosis at adjacent segment. This study will focus on the effects of preventative limited decompression at adjacent segment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Adjacent segment pathologies (ASP), including radiological adjacent segment degeneration (ASDeg) and adjacent segment disease (ASDis) after lumbar fusion surgeries have been troubling complications. The development of ASDis greatly reduces postoperative quality of life, and revision surgery may be required in severe cases. Several risk factors for ASP have been reported, such as age, sex, pre-existing adjacent degeneration, multilevel fusions, sagittal imbalance, the type of fusion, facet tropism and laminar inclination. Previous studies have reported asymptomatic pre-existing spinal canal stenosis (SCS) as a risk factor for ASDis that requires additional surgery. Appropriate strategy needs to be explored for the treatment of asymptomatic pre-existing spinal canal stenosis.

Limited decompressions, including partial laminotomy and flavectomy, have been proved to have the role of enlargement in spinal canal. Therefore, we hypothesize that limited decompressions at adjacent segment with asymptomatic pre-existing SCS will have the preventive effect on ASP.

This prospective study will be limited to patients with the same preoperative pathology, the same fusion segments (L4-5 and L5-S1), the same fusion technique (PLIF). Dynamic X-ray and MRI examinations of lumbar will be completed to evaluate the imaging manifestations of the responsible and adjacent segments before surgery. Patients with asymptomatic pre-existing canal stenosis factors (cerebrospinal fluid occlusion grade 1) at L3/4 segment will be enrolled. Patients will be randomly divided into two groups according to different strategies. NS Group includes patients who simply receive responsible segments fused (L4-S1). LD Group includes patients who receive responsible segments fused (L4-S1) plus limited decompression at adjacent segment (L3/4). In terms of limited decompression at the adjacent segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle will be performed. Complete laminectomy and destroy of posterior ligament complex will be avoided.

The patient's age, gender, preoperative body mass index (BMI), American Society of Anesthesiologists classification of anesthesia (ASA grade) will be recorded during the hospital stay. Surgical data including operation time, blood loss, perioperative complications (including cerebrospinal fluid leakage, wound infection, postoperative neurological dysfunction, and perioperative secondary surgery, cardiopulmonary complication, cerebral infarction/hemorrhage, etc.), and length of hospital stay are also recorded. Preoperative clinical function questionnaires, including visual analog scale (VAS) of low back, VAS of the legs, and Oswestry Disability Index (ODI) scores for patients were completed on admission for surgery without any assistance. All the patients enrolled will finished the follow-up from date of surgery at 1,2, 5 and 10 years. The clinical outcomes and ASP will be recorded.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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);
  • Patients have asymptomatic pre-existing spinal canal stenosis (cerebrospinal fluid occlusion grade=1) at adjacent segment.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NS Group
NS Group includes patients who simply receive responsible segments fused (L4-S1).
Procedure: Responsible segments fused
In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).
Experimental: LD Group
LD Group includes patients who receive responsible segments fused (L4-S1) plus limited decompression at adjacent segment (L3/4).
Procedure: Responsible segments fused
In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).
Procedure: Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosis
In terms of limited decompression at the adjacent segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle will be performed. Complete laminectomy and destroy of posterior ligament complex will be avoided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjacent segment degeneration
Time Frame: 12 months after surgery
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
12 months after surgery
Adjacent segment degeneration
Time Frame: 24 months after surgery
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
24 months after surgery
Adjacent segment degeneration
Time Frame: 60 months after surgery
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
60 months after surgery
Adjacent segment degeneration
Time Frame: 120 months after surgery
ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
120 months after surgery
Adjacent segment disease
Time Frame: The entire study process, up to 120 months after surgery.
ASDis is defined as clinical and radiographic evidence of degenerative spinal disease (disc degeneration, stenosis, or spondylolisthesis) on the level adjacent to the index fusion.
The entire study process, up to 120 months after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
The Oswestry Disability Index (ODI) (0-100) is used to assess disability.
12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
Back pain
Time Frame: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
The Visual Analog Scale (0-10) is used to evaluate back pain.
12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
Leg pain
Time Frame: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
The Visual Analog Scale (0-10) is used to evaluate leg pain.
12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2032

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 12, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2020285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We will make the clinical study report available for half a year after the publication of the results of the study.

IPD Sharing Time Frame

The IPD will become available for half a year after the publication of the results of the study.

IPD Sharing Access Criteria

The IPD is available to the readers of the journal in which our research is published. The corresponding author of the published papers will review the requests.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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