NCT02972190

Brief Summary

Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft-tissue structures. The investigators plan to compare the clinical and radiographic outcomes of bilateral decompression with transforaminal lumbar interbody fusion and laminectomy with posterior lumbar interbody fusion in the treatment of degenerative spondylolisthesis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

November 7, 2016

Last Update Submit

November 24, 2016

Conditions

Lumbar Spondylolisthesis

Outcome Measures

Primary Outcomes (5)

  • visual analog scale for low back pain and leg pain

    2 years postoperatively

  • Oswestry disability index

    2 years postoperatively

  • Zurich claudication questionnaire

    2 years postoperatively

  • SF-36 score

    2 years postoperatively

  • Fusion rate

    2 years postoperatively

Secondary Outcomes (7)

  • Surgery procedure duration

    Intraoperation

  • Estimated blood loss

    Intraoperation

  • Length of postoperative hospital stay

    1 week after hospital discharge

  • Complication

    2 years postoperatively

  • Degree of spondylolisthesis measured by X ray

    2 years postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Bilateral decompression with TLIF

EXPERIMENTAL

Patients undergoing bilateral decompression with TLIF

Procedure: Bilateral decompression with TLIFDevice: Pedicle screw and interbody cage

laminectomy with PLIF

ACTIVE COMPARATOR

Patients undergoing laminectomy with PLIF

Procedure: laminectomy with PLIFDevice: Pedicle screw and interbody cage

Interventions

Bilateral decompression with TLIFPROCEDURE

Bilateral decompression of neural elements combined with TLIF

Bilateral decompression with TLIF
laminectomy with PLIFPROCEDURE

Decompression of neural elements using laminectomy combined with PLIF

laminectomy with PLIF
Pedicle screw and interbody cageDEVICE

Pedicle screw and interbody cage

Bilateral decompression with TLIFlaminectomy with PLIF

Eligibility Criteria

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

You may qualify if:

  • lumbar spondylolisthesis
  • symptoms of low back pain and/or neurogenic claudication with or without radiculopathy referable to the lumbar spine,
  • at least 3 months of failed conservative therapies

You may not qualify if:

  • multilevel lumbar degenerative diseases
  • history of previous lumbar surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedic Surgery, Shanghai Ninth People's Hospital

Shanghai, 200011, China

RECRUITING

MeSH Terms

Conditions

Spondylolisthesis

Interventions

LaminectomyApoferritinsPedicle Screws

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical ProceduresApoproteinsProteinsAmino Acids, Peptides, and ProteinsFerritinsIron-Binding ProteinsCarrier ProteinsMetalloproteinsBone ScrewsInternal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Central Study Contacts

Xiaofei Cheng, MD

CONTACT

8613917556604chengxf2015@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2020

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

CN(1)