Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02972190

Enrollment

Registered

2016-11-23

Start date

2016-11-30

Completion date

2020-10-31

Last updated

2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spondylolisthesis

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.

Interventions

PROCEDUREBilateral decompression with TLIF

Bilateral decompression of neural elements combined with TLIF

PROCEDURElaminectomy with PLIF

Decompression of neural elements using laminectomy combined with PLIF

DEVICEPedicle screw and interbody cage

Pedicle screw and interbody cage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. lumbar spondylolisthesis 2. symptoms of low back pain and/or neurogenic claudication with or without radiculopathy referable to the lumbar spine, 3. at least 3 months of failed conservative therapies

Exclusion criteria

1. multilevel lumbar degenerative diseases 2. history of previous lumbar surgery

Design outcomes

Primary

Measure	Time frame
Fusion rate	2 years postoperatively
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

Secondary

Measure	Time frame
Degree of spondylolisthesis measured by X ray	2 years postoperatively
Disc space height measured by X ray	2 years postoperatively
Lumbar lordosis measured by X ray	2 years postoperatively
Surgery procedure duration	Intraoperation
Estimated blood loss	Intraoperation
Length of postoperative hospital stay	1 week after hospital discharge
Complication	2 years postoperatively

Countries

China

Contacts

Primary ContactXiaofei Cheng, MD

chengxf2015@163.com8613917556604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026