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

NCT ID: NCT04318795

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

Lumbar spinal stenosis (LSS) is one of the most common degenerative spine diseases in older people and is associated with mechanical low back pain, radiculopathy and/or neurological claudication. The results of The Spine Patient Outcomes Research Trial (SPORT) reported that, surgical treatment in these patients led to significantly greater improvement in pain and function than nonsurgical treatment. Nowadays, decompression with instrumented or non-instrumented fusion is commonly practiced which is regarded as the "gold standard" surgery for LSS.

Over the last two decades, several retrospective studies comparing the surgical outcomes of decompression alone and decompression plus fusion for LSS have been published. Most of the studies concluded that decompression plus fusion had better clinical outcomes compared with decompression alone. However, in 2016, two randomized control trials (RCT) about LSS were published in the New England Journal of Medicine (NEJM) and raised some serious questions. The results of both studies showed that fusion did not have much additional value for patients with stable LSS, and moreover, it might be regard as an overcautious and unnecessary treatment, which were contradictory to most of the previous studies.

Over the past few years, minimally invasive spine surgery (MISS) has been improving rapidly due to the development of related instruments, more experienced surgeons, and patients' demands. Compared with open spine surgery, MISS has already proved to be associated with less surgical trauma and rapid recovery with similar clinical outcomes. Minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF) have been performed widely for the treatment of LSS. However, there is no previous study comparing MIS-D to MIS-TLIF in terms of clinical outcomes, complications, reoperations, and other perioperative data. Therefore, a randomized controlled trial comparing these 2 common MISS techniques is warranted.

Conditions

Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

minimally invasive spinal decompression (MIS-D)

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

Group Type: EXPERIMENTAL

minimally invasive spinal decompression (MIS-D)

Intervention Type: PROCEDURE

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

minimally invasive spinal decompression and fusion (MIS-TLIF)

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

Group Type: EXPERIMENTAL

minimally invasive spinal decompression and fusion (MIS-TLIF)

Intervention Type: PROCEDURE

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

Interventions

minimally invasive spinal decompression (MIS-D)

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

Intervention Type: PROCEDURE

minimally invasive spinal decompression and fusion (MIS-TLIF)

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Limin Rong

Prof., M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MIS-D V.s. MIS-TLIF for LSS

Identifier Type: -

Identifier Source: org_study_id