Clinical Trials Logo
  1. Home
  2. Lumbar Spinal Stenosis
  3. NCT04946487
  4. Details
NCT04946487 Clinical Trial

Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery

Lumbar Spinal Stenosis Clinical Trial

Official title:
Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04946487
Other study ID # M2019232
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date December 30, 2022

Study information
Verified date June 2021
Source Peking University Third Hospital
Contact Zhuofu Li
Phone 15620610715
Email 840764209@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF)

Description:

Purpose: To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF). Methods: This retrospective study was performed in patients who received L5/S1 PLIF with pedicle screw instrumentation for lumbar spinal stenosis with or without isthmic spondylolisthesis. They were divided into the total laminectomy group, which had destruction of the PLC of the adjacent segment, or partial laminectomy group, which did not. Vertebral slip, osteophytes, disk height, and range of motion were examined by plain radiography, and thickness of the ligamentum flavum (LF) and anteroposterior diameters of the lumbar vertebral body and spinal canal were assessed by magnetic resonance imaging (MRI). Disc degeneration and spinal stenosis on MRI scans were categorized. The incidence of ASD and clinical outcome were compared between the groups.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers
Gender All
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria: - typical clinical symptoms such as disabling low back or leg pain with or without neurological symptoms, intermittent claudication, with refractory to =6 months of strict conservative treatment; and L5/S1 single-level PLIF with pedicle screw instrumentation. Exclusion Criteria: - previous spine surgery, acute spinal fracture, infection, and tumor.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• total laminectomy
Total laminectomy removes the posterior ligamentous complex (PLC) at the fusion and superior levels.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary the Incidences of adjacent segment degeneration the Incidences of adjacent segment degeneration From the end of treatment to more than 8 years
See also
  Status Clinical Trial Phase
Recruiting NCT04795284 - Biomechanical Parameters of Gait in Patients With Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
Recruiting NCT04066296 - Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine Phase 2
Active, not recruiting NCT05114135 - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study) N/A
Recruiting NCT06075862 - Balance Amongst Patients With Lumbar Spinal Stenosis
Recruiting NCT06057428 - Activity Levels Amongst Patients With Lumbar Spinal Stenosis
Recruiting NCT05527145 - Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial N/A
Recruiting NCT01902979 - The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial N/A
Completed NCT00749073 - The Vertos MILD™ Preliminary Patient Evaluation Study N/A
Completed NCT00527527 - Chiropractic Dosage for Lumbar Stenosis Phase 2
Completed NCT00405691 - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis Phase 3
Completed NCT03194607 - Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
Recruiting NCT06034405 - Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Completed NCT06079580 - Patients With Lumbar Spinal Stenosis With Balance Disorder
Recruiting NCT05523388 - Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Completed NCT04563793 - Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Suspended NCT03381677 - Pedicle Osteotomy for Stenosis Trial N/A
Completed NCT02258672 - Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis N/A
Completed NCT02260401 - Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis N/A
Completed NCT00401518 - A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis N/A