Minimal Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Lumbar and Lumbosacral Spine Diseases

August 6, 2024 updated by: Abdelaleem Mohamed Abdelrahman, Sohag University

Minimal Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Lumbar and Lumbosacral Spine Diseases : Clinical and Surgical Outcome

The aim of this study is to evaluate clinical and surgical outcome of MI-TLIF for degenerative lumbar and lumbosacral spine diseases.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 70% to 85% of adults were affected by low back pain (LBP) at some point during their lifetimes. Numerous anatomic sites can be responsible for the pain, and accurate diagnosis is often difficult. Degenerative lumbar, lumbosacral spine diseases internal disc disruption, lumbar disc herniation, and facet joint arthritis, as well as intra-abdominal pathology, are all potential causes of LBP(Stott and Driscoll, 2024). q Degenerative lumbar and lumbosacral spine diseases are the most rampantly prevalent healthcare problems in the world, with chronic LBP being the second leading cause of adult disability ,The symptoms can broadly be divided into LBP and radicular symptoms in the lower extremities leading in some cases to neurogenic claudication(Shokri et al., 2023).

As an alternative to PLIF, Harms and Rolinger introduced the transforaminal lumbar interbody fusion (TLIF) procedure in 1982 for the management of degenerative spinal disorders that necessitate interbody fusions. The impetus for the development of TLIF was to provide a more lateral approach to the disc space, thus reducing the amount of thecal sac and nerve root retraction. Additionally, in revision cases where scar tissue hinders identification of neural structures, avoidance of midline scar planes with the TLIF procedure is beneficial. Moreover, a circumferential fusion can be achieved from a unilateral approach with the TLIF procedure without having to expose the bilateral epidural space (Karikari, Isaac O. MD; Isaacs, Robert E. MD, 2010).

Technological advances, better magnification and illumination, modern tubular retractors and percutaneous screw systems and more frequent exposure of surgeons to minimally access surgery in their residency training has greatly contributed to the global success of minimal invasive transforaminal lumbar interbody fusion (MI-TLIF). Traditional open spinal fusion surgeries, while effective, are associated with considerable tissue disruption, prolonged recovery times, and higher risks of complications(Prabhu et al., 2022).

MI-TLIFis one such advanced surgical technique designed to treat degenerative conditions of lumbar and lumbosacral spine diseases. Through the tubular expander, MIS-TLIF can reach the facet joints of the diseased segments. MIS-TLIF effectively reduces the peeling and traction injury of the multifidus muscle, prevents postoperative muscle atrophy, and reduces the occurrence of postoperative chronic LBP(Saela et al., 2023).

The MI-TLIF has shown reduced complications, decreased intraoperative blood loss, shorter hospital stays and recovery time, and decreased postoperative narcotic usage while maintaining similar clinical outcomes and fusion rates to conventional open TLIF since its inception (Hong et al., 2022).

The success of MI-TLIF can be attributed to the following fundamental principles: (1) minimizing damage to soft tissues and avoiding destabilization of the spinal segment(s) to achieve the surgical goal with the smallest possible operative footprint; (2) utilizing a unilateral approach to achieve bilateral decompression when needed; and (3) achieving neural decompression indirectly. Although there is no definitive definition of MI-TLIF, the lack of a precise definition has led to significant variations in how surgeons perform the procedure due to various technical nuances associated with each step(Lener et al., 2020).

The use of minimally invasive surgical techniques represents the most recent modification of methods used to achieve lumbar interbody fusion, based upon the premise that a smaller, less traumatic incision should afford better recovery and outcomes(Jang et al., 2024).Hence, in our study we aim to evaluate MI-TLIF for degenerative lumbar and lumbosacral spine diseases.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Degenerative spondylolisthesis.
  • Degenerative unilateral disc herniations.
  • Recurrent disc herniation.

Exclusion Criteria:

  • Spondylolisthesis Grade III or IV.
  • Degenerative scoliosis .
  • Traumatic fracture spine.
  • Infections.
  • Neoplasms.
  • Debilitated patients .
  • Coagulation dysfunction.
  • Severe osteoporosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity of pain according to visual analog score(vas)
Time Frame: 1 year
comparison between pre & post operative pain
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-med-24-07-3MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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