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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04318795
Study type	Interventional
Source	Third Affiliated Hospital, Sun Yat-Sen University
Contact
Status	Not yet recruiting
Phase	N/A
Start date	June 1, 2020
Completion date	December 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06290908` - RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
Withdrawn	`NCT03223701` - Efficacy of Using Solum IV and BMC With GFC in TLIF	Phase 4
Recruiting	`NCT03883022` - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery	N/A
Completed	`NCT02902380` - The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery	N/A
Not yet recruiting	`NCT06024785` - Vertebropexy - Randomized-controlled Trial	N/A
Not yet recruiting	`NCT06000319` - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Completed	`NCT02558621` - New Robotic Assistance System for Spinal Fusion Surgery	N/A
Completed	`NCT02454400` - Pre-surgery Physiotherapy for Patients With Specific Low Back Pain	N/A
Completed	`NCT01377623` - Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion	N/A
Terminated	`NCT00974623` - Bone Graft Materials Observational Registry	N/A
Completed	`NCT00996073` - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion	Phase 2
Completed	`NCT00022776` - Surgical Versus Nonsurgical Treatment for Spinal Stenosis	Phase 3
Completed	`NCT00320619` - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery	N/A
Completed	`NCT06060821` - Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
Recruiting	`NCT04552145` - Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis	N/A
Active, not recruiting	`NCT04379921` - Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch	N/A
Withdrawn	`NCT04315090` - Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
Completed	`NCT04591249` - Physical Activity Intervention for Patients Following Lumbar Spine Surgery	N/A
Recruiting	`NCT04601363` - Personalized Spine Study Group (PSSG) Registry
Completed	`NCT04193488` - Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery	N/A