Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

Lumbar Spondylolisthesis Clinical Trial

Official title:

Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02972190
• Other study ID #: SNPHO-161107
• Status: Recruiting
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 24, 2016
• Start date: November 2016
• Est. completion date: October 2020

Study information

• Verified date: November 2016
• Source: Shanghai 9th People's Hospital
• Contact: Xiaofei Cheng, MD
• Phone: 8613917556604
• Email: chengxf2015[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2020
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Spondylolisthesis
• Spondylolisthesis

Intervention

Procedure:
• Bilateral decompression with TLIF
Bilateral decompression of neural elements combined with TLIF
• laminectomy with PLIF
Decompression of neural elements using laminectomy combined with PLIF

Device:
• Pedicle screw and interbody cage
Pedicle screw and interbody cage

Locations

Country	Name	City	State
China	Department of Orthopedic Surgery, Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 9th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale for low back pain and leg pain		2 years postoperatively	No
Primary	Oswestry disability index		2 years postoperatively	No
Primary	Zurich claudication questionnaire		2 years postoperatively	No
Primary	SF-36 score		2 years postoperatively	No
Primary	Fusion rate		2 years postoperatively	No
Secondary	Surgery procedure duration		Intraoperation	No
Secondary	Estimated blood loss		Intraoperation	No
Secondary	Length of postoperative hospital stay		1 week after hospital discharge	No
Secondary	Complication		2 years postoperatively	No
Secondary	Degree of spondylolisthesis measured by X ray		2 years postoperatively	No
Secondary	Disc space height measured by X ray		2 years postoperatively	No
Secondary	Lumbar lordosis measured by X ray		2 years postoperatively	No