NCT04469387

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
76mo left

Started Sep 2020

Longer than P75 for not_applicable

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 Progress48%
Sep 2020Aug 2032

First Submitted

Initial submission to the registry

July 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2032

Expected
Last Updated

September 18, 2020

Status Verified

June 1, 2020

Enrollment Period

1.9 years

First QC Date

July 8, 2020

Last Update Submit

September 16, 2020

Conditions

Degenerative Lumbar Spinal StenosisDegenerative Disc DiseaseDegeneration Spine

Keywords

Adjacent segment degenerationAdjacent segment diseasePre-existing degenerationLimited decompression

Outcome Measures

Primary Outcomes (5)

  • Adjacent segment degeneration

    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 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 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 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 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 (2)

NS Group

ACTIVE COMPARATOR

NS Group includes patients who simply receive responsible segments fused (L4-S1).

Procedure: Responsible segments fused

LD Group

EXPERIMENTAL

LD Group includes patients who receive responsible segments fused (L4-S1) plus limited decompression at adjacent segment (L3/4).

Procedure: Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosisProcedure: Responsible segments fused

Interventions

Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosisPROCEDURE

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.

LD Group
Responsible segments fusedPROCEDURE

In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).

LD GroupNS Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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);
  • Patients have asymptomatic pre-existing spinal canal stenosis (cerebrospinal fluid occlusion grade=1) at adjacent segment.
  • 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 (7)

  • 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

  • Zhong ZM, Deviren V, Tay B, Burch S, Berven SH. Adjacent segment disease after instrumented fusion for adult lumbar spondylolisthesis: Incidence and risk factors. Clin Neurol Neurosurg. 2017 May;156:29-34. doi: 10.1016/j.clineuro.2017.02.020. Epub 2017 Feb 27.

    PMID: 28288396RESULT

  • Alentado VJ, Lubelski D, Healy AT, Orr RD, Steinmetz MP, Benzel EC, Mroz TE. Predisposing Characteristics of Adjacent Segment Disease After Lumbar Fusion. Spine (Phila Pa 1976). 2016 Jul 15;41(14):1167-1172. doi: 10.1097/BRS.0000000000001493.

    PMID: 26863261RESULT

  • Hikata T, Kamata M, Furukawa M. Risk factors for adjacent segment disease after posterior lumbar interbody fusion and efficacy of simultaneous decompression surgery for symptomatic adjacent segment disease. J Spinal Disord Tech. 2014 Apr;27(2):70-5. doi: 10.1097/BSD.0b013e31824e5292.

    PMID: 22460400RESULT

  • Matsumoto T, Okuda S, Nagamoto Y, Sugiura T, Takahashi Y, Iwasaki M. Effects of Concomitant Decompression Adjacent to a Posterior Lumbar Interbody Fusion Segment on Clinical and Radiologic Outcomes: Comparative Analysis 5 Years After Surgery. Global Spine J. 2019 Aug;9(5):505-511. doi: 10.1177/2192568218803324. Epub 2018 Oct 8.

    PMID: 31431873RESULT

  • 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

  • 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 Degeneration

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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 14, 2020

Study Start

September 1, 2020

Primary Completion

August 1, 2022

Study Completion (Estimated)

August 1, 2032

Last Updated

September 18, 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)