NCT05929755 · Hardeep Singh
Depo-Medrol on Psoas After LLIF
What this study is about
The goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) on postoperative hip flexor weakness and thigh pain and numbness.
View original scientific description
The goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) on postoperative hip flexor weakness and thigh pain and numbness.
Interventions
DRUG
Depo-Medrol
steroid
DRUG
Gel-Flow NT
hemostatic agent
Primary outcome measures
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
Time frame: 2-3 weeks following surgery
Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
Time frame: 6 weeks following surgery
Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
Time frame: 12 weeks following surgery
Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients from the practices of Drs. Singh, Mallozzi, Moss
- Transpsoas (PTP or LTP) lateral lumbar interbody fusion (LLIF) 1-3 disc levels with posterior instrumentation (Open or MIS) with or without laminectomy, must include L3-4 and/or L4-5
- Patients who agree to be a part of the study
- Patients with lumbar disc degeneration
- Patients between ages of 18 and 75
Exclusion criteria
- Scoliosis \>10°
- Spondylolisthesis \>Grade 1
- Flatback deformity
- Patients with insulin dependent diabetes
- Patients with \>3 levels of fusion
- Alternative interbodies
- Chronic oral steroid users
- Patients with allergy/intolerance to depo-medrol or other steroids
- Patients requiring bilateral transpsoas approaches
- Patients with ipsilateral symptomatic hip pathology
- Revision fusion procedures
- Cases involving trauma, tumor, or infection
- Patient's not capable of providing consent themselves
- Non-fluent English speakers (for consenting reasons)
- Patients who are lost to follow-up before the two year follow up period
Where
- Farmington, Connecticut
Collaborators
Society for Minimally Invasive Spine Surgery
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2025 · Source of record for eligibility and locations