MIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis

NCT04318795 | Unknown DMC

• 1 other identifier: MIS-D V.s. MIS-TLIF for LSS
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness of two minimal invasive spine surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF), for patients diagnosed with lumbar spinal stenosis in terms of clinical outcomes, complications, reoperations, and other perioperative data.

Conditions

Spinal Stenosis

Keywords

lumbar spinal stenosis; minimally invasive spine surgery; decompression; fusion; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• change in Oswestry Disability Index (ODI) score from baseline

  The Oswestry Disability Index (ODI) is widely used to assess chronic low back pain. It contains ten sections including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The ODI is ranging from 0 to 100, with higher scores indicating more disability related to pain.

  preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively

Secondary Outcomes (3)

• change in European Quality of Life-5 Dimensions (EQ-5D) from baseline

  preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively

• change in visual analog scales (VAS) from baseline

  preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively

• MacNab criteria

  2 month, 6 months, 1 year，2 years and 5 years postoperatively

Study Arms (2)

minimally invasive spinal decompression (MIS-D)

EXPERIMENTAL

lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation

Procedure: minimally invasive spinal decompression (MIS-D)

minimally invasive spinal decompression and fusion (MIS-TLIF)

EXPERIMENTAL

lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach

Procedure: minimally invasive spinal decompression and fusion (MIS-TLIF)

Interventions

minimally invasive spinal decompression (MIS-D) PROCEDURE

lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation

minimally invasive spinal decompression (MIS-D)

minimally invasive spinal decompression and fusion (MIS-TLIF) PROCEDURE

lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach

minimally invasive spinal decompression and fusion (MIS-TLIF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intermittent claudication with pain or numbness or weakness of lower limb(s) with or without low back pain
• An imaging study (MRI or CT) showing single level lumbar spinal stenosis

You may not qualify if:

• Insufficient conservative treatment (6 weeks)
• Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
• Previous spinal surgery
• Other comorbid conditions that contraindicating surgery
• Possible pregnancy that contraindicating radiological examination
• Age less than 18 years old
• Combination with 2°spondylolisthesis or segmental instability (slip distance \>4mm or angle change \>10° in dynamic plain film)
• Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
• Equal to or more than two responsible level

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., M.D.

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 24, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2025
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share