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

Minimally Invasive Spinal Decompression (MIS-D) Versus Minimally Invasive Spinal Decompression and Fusion (MIS-TLIF) for the Treatment of Lumbar Spinal Stenosis (LSS): A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Stenosis
• Intervention / Treatment: Procedure: minimally invasive spinal decompression (MIS-D); Procedure: minimally invasive spinal decompression and fusion (MIS-TLIF)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: minimally invasive spinal decompression (MIS-D); lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation	Procedure: minimally invasive spinal decompression (MIS-D); lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation
Experimental: minimally invasive spinal decompression and fusion (MIS-TLIF); lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach	Procedure: minimally invasive spinal decompression and fusion (MIS-TLIF); lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in European Quality of Life-5 Dimensions (EQ-5D) from baseline	The EQ-5D is a widely used instrument to assess health-related quality of life. Five questions(Mobility, Self-care, activities of daily living, Pain and Anxiety) are categorical (1-3 scale) and one question is on interval level (0-100).The EQ-5D is ranging from 0 to 1, with a higher score indicating better quality of life.	preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
change in visual analog scales (VAS) from baseline	The VAS score is commonly used for pain assessment, which is ranging from 0 to 10, with higher scores indicating more severe pain	preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
MacNab criteria	The patient is asked to rate his level of well-being, generally after surgery. The patient choose one of the four: Excellent, Good, Fair, Poor.	2 month, 6 months, 1 year，2 years and 5 years postoperatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; fusion; decompression; minimally invasive spine surgery; lumbar spinal stenosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: MIS-D V.s. MIS-TLIF for LSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No