NCT04467944

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress56%
Jan 2018Dec 2032

Study Start

First participant enrolled

January 1, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Expected
Last Updated

July 13, 2020

Status Verified

June 1, 2020

Enrollment Period

5 years

First QC Date

June 28, 2020

Last Update Submit

July 8, 2020

Conditions

Degenerative Lumbar Spinal StenosisDegenerative Disc DiseaseDegeneration Spine

Keywords

Cerebrospinal fluid occlusionPre-existing degenerationSpinal canal stenosisAdjacent segment degenerationAdjacent segment diseaseHigh-intensity zoneVacuum sign

Outcome Measures

Primary Outcomes (5)

  • Adjacent segment degeneration (ASDeg)

    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 (ASDeg)

    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 (ASDeg)

    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 (ASDeg)

    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 (ASDis)

    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 Outcomes (3)

  • Disability

    12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.

  • Back pain

    12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.

  • Leg pain

    12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.

Study Arms (3)

NS Group

Patients without pre-existing degeneration at L3/4 segment will be classified into control group (NS group).

D Group

Patients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or vacuum sign) at L3/4 segment will be classified into group D.

Other: Pre-existing degenerative factors at adjacent segment

C Group

Patients with pre-existing canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified into group C.

Other: Pre-existing degenerative factors at adjacent segment

Interventions

Pre-existing degenerative factors at adjacent segmentOTHER

Pre-existing degenerative factors at adjacent segment, including disc factors and canal stenosis factors

C GroupD Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In the orthopaedic department of Peking University Third Hospital, patients with a clear diagnosis of lumbar degenerative disease, and surgical level of L4-S1 will be enrolled.

You may qualify if:

  • 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;

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (6)

  • Lee JC, Kim Y, Soh JW, Shin BJ. Risk factors of adjacent segment disease requiring surgery after lumbar spinal fusion: comparison of posterior lumbar interbody fusion and posterolateral fusion. Spine (Phila Pa 1976). 2014 Mar 1;39(5):E339-45. doi: 10.1097/BRS.0000000000000164.

    PMID: 24365899RESULT

  • Lawrence BD, Wang J, Arnold PM, Hermsmeyer J, Norvell DC, Brodke DS. Predicting the risk of adjacent segment pathology after lumbar fusion: a systematic review. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S123-32. doi: 10.1097/BRS.0b013e31826d60d8.

    PMID: 22885827RESULT

  • Yugue I, Okada S, Masuda M, Ueta T, Maeda T, Shiba K. Risk factors for adjacent segment pathology requiring additional surgery after single-level spinal fusion: impact of pre-existing spinal stenosis demonstrated by preoperative myelography. Eur Spine J. 2016 May;25(5):1542-1549. doi: 10.1007/s00586-015-4185-6. Epub 2015 Aug 14.

    PMID: 26272373RESULT

  • Lee GY, Lee JW, Choi HS, Oh KJ, Kang HS. A new grading system of lumbar central canal stenosis on MRI: an easy and reliable method. Skeletal Radiol. 2011 Aug;40(8):1033-9. doi: 10.1007/s00256-011-1102-x. Epub 2011 Feb 1.

    PMID: 21286714RESULT

  • Mysliwiec LW, Cholewicki J, Winkelpleck MD, Eis GP. MSU classification for herniated lumbar discs on MRI: toward developing objective criteria for surgical selection. Eur Spine J. 2010 Jul;19(7):1087-93. doi: 10.1007/s00586-009-1274-4. Epub 2010 Jan 19.

    PMID: 20084410RESULT

  • Nakashima H, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A, Tauchi R, Ohta K, Hamajima N, Imagama S. Adjacent Segment Disease After Posterior Lumbar Interbody Fusion: Based on Cases With a Minimum of 10 Years of Follow-up. Spine (Phila Pa 1976). 2015 Jul 15;40(14):E831-41. doi: 10.1097/BRS.0000000000000917.

    PMID: 25839385RESULT

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Wei Shi Li, Dr.

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuo Ran Sun, Dr.

CONTACT

+8618610292513puh3_szr@outlook.com

Study Design

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

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 13, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2032

Last Updated

July 13, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
CSR
Time Frame
The IPD will become available for half a year after the publication of the results of the study.
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.

Locations

CN(1)