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Trial record 3 of 42 for:    Recruiting, Not yet recruiting, Available Studies | "Spondylolisthesis"

Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

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ClinicalTrials.gov Identifier: NCT02972190
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaofei Cheng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment Phase
Lumbar Spondylolisthesis Procedure: Bilateral decompression with TLIF Procedure: laminectomy with PLIF Device: Pedicle screw and interbody cage Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
Study Start Date : November 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: Bilateral decompression with TLIF
Patients undergoing bilateral decompression with TLIF
Procedure: Bilateral decompression with TLIF
Bilateral decompression of neural elements combined with TLIF

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

Active Comparator: laminectomy with PLIF
Patients undergoing laminectomy with PLIF
Procedure: laminectomy with PLIF
Decompression of neural elements using laminectomy combined with PLIF

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




Primary Outcome Measures :
  1. visual analog scale for low back pain and leg pain [ Time Frame: 2 years postoperatively ]
  2. Oswestry disability index [ Time Frame: 2 years postoperatively ]
  3. Zurich claudication questionnaire [ Time Frame: 2 years postoperatively ]
  4. SF-36 score [ Time Frame: 2 years postoperatively ]
  5. Fusion rate [ Time Frame: 2 years postoperatively ]

Secondary Outcome Measures :
  1. Surgery procedure duration [ Time Frame: Intraoperation ]
  2. Estimated blood loss [ Time Frame: Intraoperation ]
  3. Length of postoperative hospital stay [ Time Frame: 1 week after hospital discharge ]
  4. Complication [ Time Frame: 2 years postoperatively ]
  5. Degree of spondylolisthesis measured by X ray [ Time Frame: 2 years postoperatively ]
  6. Disc space height measured by X ray [ Time Frame: 2 years postoperatively ]
  7. Lumbar lordosis measured by X ray [ Time Frame: 2 years postoperatively ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972190


Contacts
Contact: Xiaofei Cheng, MD 8613917556604 chengxf2015@163.com

Locations
China
Department of Orthopedic Surgery, Shanghai Ninth People's Hospital Recruiting
Shanghai, China, 200011
Contact: Xiaofei Cheng, MD    8613917556604    chengxf2015@163.com   
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Responsible Party: Xiaofei Cheng, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02972190     History of Changes
Other Study ID Numbers: SNPHO-161107
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases