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Search / Trial NCT05929755

Depo-Medrol on Psoas After LLIF

Launched by HARDEEP SINGH · Jun 29, 2023

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Lateral Lumbar Interbody Fusion Llif Depo Medrol Corticosteroid Lumbar Spine Psoas Muscle Postoperative Hip Flexor Weakness Postoperative Thigh Pain Postoperative Thigh Numbness

ClinConnect Summary

This clinical trial is studying the effects of a medication called Depo-Medrol, which is a type of corticosteroid, when given to the psoas muscle after a specific spinal surgery known as lateral lumbar interbody fusion (LLIF). The main goal is to see if this treatment can help reduce muscle weakness, thigh pain, and numbness that some patients may experience after their surgery. The trial is currently looking for participants, specifically adults aged 18 to 75 who have undergone LLIF for issues like lumbar disc degeneration.

To be eligible for the study, patients must be receiving care from certain doctors and have had surgery involving 1 to 3 disc levels in their lower back. However, there are some conditions that would prevent a person from participating, such as having severe spinal deformities, certain medical conditions like diabetes, or if they've had too many levels of surgery. Participants in the trial can expect to receive the corticosteroid treatment and will be monitored for up to two years to see how it affects their recovery. This trial is important because it could provide new insights into improving recovery for patients undergoing back surgery.

Gender

ALL

Eligibility criteria

  • 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

About Hardeep Singh

Hardeep Singh is a dedicated clinical trial sponsor with a robust commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapies and evidence-based practices, Singh leads initiatives that prioritize ethical standards and regulatory compliance throughout the clinical trial process. His expertise in trial design, patient engagement, and data integrity ensures the generation of high-quality evidence that supports the development of new treatments across various therapeutic areas. Singh's collaborative approach with clinical sites and stakeholders fosters a dynamic research environment aimed at addressing unmet medical needs.

Locations

Farmington, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Hardeep Singh, M.D.

Principal Investigator

UConn Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported