Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

NCT02972190 — Not applicable, Unknown, 90 participants, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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Registry	NCT02972190
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	90 (Estimated)
Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Conditions	Lumbar Spondylolisthesis
Interventions	Bilateral decompression with TLIF, laminectomy with PLIF, Pedicle screw and interbody cage (Procedure, device)
Dates	start 2016-11-01, primary completion 2018-10-01 (estimated), completion 2020-10-01 (estimated), first posted 2016-11-23, last updated 2016-11-28
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Bilateral decompression with TLIF	Experimental	Procedure: Bilateral decompression with TLIF; Device: Pedicle screw and interbody cage	Patients undergoing bilateral decompression with TLIF
laminectomy with PLIF	Active comparator	Procedure: laminectomy with PLIF; Device: Pedicle screw and interbody cage	Patients undergoing laminectomy with PLIF

Bilateral decompression with TLIF (Procedure): Bilateral decompression of neural elements combined with TLIF
laminectomy with PLIF (Procedure): Decompression of neural elements using laminectomy combined with PLIF
Pedicle screw and interbody cage (Device): Pedicle screw and interbody cage

+Outcome measures

Primary outcomes

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

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]
Disc space height measured by X ray [2 years postoperatively]
Lumbar lordosis measured by X ray [2 years postoperatively]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (1)

Facility	City	Country	Status
Department of Orthopedic Surgery, Shanghai Ninth People's Hospital	Shanghai	China	Recruiting