Pre-op vs Intra-op TLIP for Spinal Fusion

Recruiting in Palo Alto (17 mi)

Overseen by Daniel Park, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: William Beaumont Hospitals

Must not be taking: Cocaine, THC

Disqualifiers: Under 18, Revision surgery, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Single-center, randomized study will enroll 50 subjects who are scheduled for 1-3 level posterior laminectomy \& fusion. Study participants who are eligible for the posterior lumbar laminectomy and fusion procedure will be scheduled and also consented as a part of the study. Participants will be stratified based on age and gender to ensure equal distribution.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that your daily morphine milligram equivalent (MME) is less than 25 MME per day before the operation. If you are taking medications that affect this, you may need to adjust them.

What data supports the effectiveness of the treatment Intraoperative TLIP, Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Interbody Fusion (PLIF), Preoperative Ultrasound TLIP, Preoperative Ultrasound TLIP, Transforaminal Lumbar Interbody Fusion, TLIF?

The research indicates that both TLIF and PLIF are well-established procedures for spinal fusion, with TLIF offering advantages such as reduced risk of nerve injury and better alignment of the spine. These techniques have shown increased fusion rates, especially when combined with bone grafts and supportive hardware.

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Is TLIP for spinal fusion generally safe for humans?

Transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) are well-established procedures for spinal fusion, but they can have complications that sometimes require additional surgery. While these procedures are popular and widely used, there is a risk of complications that may lead to reoperation within two years.

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How does the treatment Pre-op vs Intra-op TLIP for Spinal Fusion differ from other treatments for spinal fusion?

The Pre-op vs Intra-op TLIP for Spinal Fusion treatment is unique because it compares the timing of the TLIP procedure, either before (pre-op) or during (intra-op) surgery, which is not commonly addressed in standard spinal fusion techniques. This approach may offer insights into optimizing surgical outcomes and recovery by evaluating the benefits of preoperative ultrasound guidance versus traditional intraoperative methods.

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Eligibility Criteria

This trial is for adults over 18 needing a specific back surgery (1-3 level posterior laminectomy with fusion) and taking low doses of pain medication. They must agree to follow the study plan and attend check-ups after surgery. People under 18, not consenting, requiring revision surgery, using certain drugs, or involved in lawsuits can't join.

Inclusion Criteria

I take less than 25 MME of pain medication daily before surgery.

Compliant with study requirements and outpatient follow-up

I am 18 years old or older.

Exclusion Criteria

Ongoing lawsuits, workers compensation, and litigation will be excluded.

A positive drug screen for cocaine and/or tetrahydrocannabinol (THC), defined in the standard Corewell Drugs of Abuse Screening as cocaine > 300 ng/mL and cannabinoid > 50 ng/mL-any

I take less than 25 MME of pain medication daily before surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Demographics and medical history are collected, and participants are stratified based on age and gender

1 week

Treatment

Participants undergo 1-3 level posterior lumbar laminectomy and fusion procedure with either pre-op or intra-op TLIP block

Surgery day

1 visit (in-person)

Postoperative Monitoring

Pain and opioid analgesia are assessed using VAS and Likert scales at various intervals post-surgery

3 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including satisfaction and adverse events

3 months

Participant Groups

The study compares two timing approaches for administering TLIP anesthesia: one before surgery (Pre-op) and another during the operation (Intra-op). It's designed to see which method works better for pain management in spinal fusion patients.

Group I: Preoperative Ultrasound TLIP Group Active Control 1 Intervention

Participant will receive TLIP in preop with 20cc of 0.2% ropivacaine administered bilaterally, 40cc total. Blocks will be performed under ultrasound guidance with an in-plane technique by a single study investigator.

Group II: Intraoperative TLIP Group Active Control 1 Intervention

Participants will receive TLIP with 20cc of 0.2% ropivacaine bilaterally, 40cc total. Blocks will be performed intraoperatively under direct surgical visualization.

Intraoperative TLIP is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis

🇪🇺 Approved in European Union as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis
• Scoliosis

🇨🇦 Approved in Canada as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis

🇯🇵 Approved in Japan as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

William Beaumont Hospital Royal Oak, MI

Who Is Running the Clinical Trial?

William Beaumont Hospitals Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Load distribution on intervertebral cages with and without posterior instrumentation. [2023] Posterior and transforaminal lumbar interbody fusion (PLIF, TLIF) are well-established procedures for spinal fusion. However, little is known about load sharing between cage, dorsal construct, and biological tissue within the instrumented lumbar spine.

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of low back fusion techniques: transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody fusion (PLIF) approaches. [2022] The authors review and compare posterior lumbar interbody fusion (PLIF) with transforaminal lumbar interbody fusion (TLIF). A review of the literature is performed wherein the history, indications for surgery, surgical procedures with their respective biomechanical advantages, potential complications, and grafting substances are presented. Along with the technical advancements and improvements in grafting substances, the indications and use of PLIF and TLIF have increased. The rate of arthrodesis has been shown to increase given placement of bone graft along the weight-bearing axis. The fusion rate across the disc space is further enhanced with the placement of posterior pedicle screw-rod constructs and the application of an osteoinductive material. The chief advantages of the TLIF procedure compared with the PLIF procedure included a decrease in potential neurological injury, improvement in lordotic alignment given graft placement within the anterior column, and preservation of posterior column integrity through minimizing lamina, facet, and pars dissection.

3. Germany pubmed.ncbi.nlm.nih.gov

A comparative study of perioperative complications between transforaminal versus posterior lumbar interbody fusion in degenerative lumbar spondylolisthesis. [2022] Both posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) are accepted surgical techniques for the treatment of degenerative lumbar spondylolisthesis (DLS). However, it is still unclear one technique offers distinct advantages over the other.

4. England pubmed.ncbi.nlm.nih.gov

Comparison of PLIF and TLIF in the Treatment of LDH Complicated with Spinal Stenosis. [2022] The purpose was to compare the clinical effects of posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) in the treatment of lumbar disc herniation (LDH) complicated with spinal stenosis.

5. Germany pubmed.ncbi.nlm.nih.gov

[The PLIF and TLIF techniques. Indication, technique, advantages, and disadvantages]. [2018] Posterior fusion procedures (posterior lumbar interbody fusion, PLIF; transforaminal lumbar interbody fusion, TLIF) are long-established surgical techniques for lumbar interbody fusion. They differ from anterior lumbar interbody fusion (ALIF) and extreme lateral interbody fusion (XLIF) procedures by approach and associated complications.

6. United States pubmed.ncbi.nlm.nih.gov

Biomechanical comparison of posterior lumbar interbody fusion and transforaminal lumbar interbody fusion by finite element analysis. [2013] The transforaminal lumbar interbody fusion (TLIF) procedure may reduce many of the risks and limitations associated with posterior lumbar interbody fusion (PLIF). However, little is known about the biomechanical difference between PLIF and TLIF.

7. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of the early results of transforaminal lumbar interbody fusion and posterior lumbar interbody fusion in symptomatic lumbar instability. [2022] Transforaminal lumbar interbody fusion (TLIF) has been preferred to posterior lumbar interbody fusion (PLIF) for different spinal disorders but there had been no study comparing their outcome in lumbar instability. A comparative retrospective analysis of the early results of TLIF and PLIF in symptomatic lumbar instability was conducted between 2005 and 2011.

8. Germany pubmed.ncbi.nlm.nih.gov

Successful salvage strategy using anterior retroperitoneal approach in failed posterior lumbar interbody fusion. A retrospective analisys on lumbar lordosis and clinical outcome. [2022] Posterior and transforaminal lumbar interbody fusion (PLIF, TLIF) are among the most popular surgical options for lumbar interbody fusion. If non-union occurs with consequent pain and reduced quality of life, revision surgery should correct any previous technical errors, avoiding further complications. The aim of this study was to analyze technical advantages, radiological and clinical outcomes of anterior approaches (ALIF) in case of failed PLIF or TLIF.

9. Germany pubmed.ncbi.nlm.nih.gov

Reoperation within 2 years after lumbar interbody fusion: a multicenter study. [2021] Posterior lumbar interbody fusion (PLIF)/transforaminal lumbar interbody fusion (TLIF) can have complications that require reoperation. The goal of the study was to identify risk factors for reoperation within 2 years after PLIF/TLIF.

10. United States pubmed.ncbi.nlm.nih.gov

A retrospective controlled study protocol of transforaminal lumbar interbody fusion compared with posterior lumbar interbody fusion for spondylolisthesis. [2022] In the current literature, for adult lumbar spondylolisthesis, the direct comparison of clinical outcomes and perioperative complications between transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) is limited. Whether the therapeutic effect of TLIF is better than that of PLIF is still controversial. In this retrospective controlled study, our aim was to compare their clinical outcomes and radiological results of the above two stabilization approaches after 1-year follow-up period.