Recruiting PHASE4 Muscle Weakness

New treatment option for Muscle Weakness

Official title Depo-Medrol on Psoas After LLIF

ClinicalTrials.gov ID: NCT05929755

What this study is testing

What is Depo-Medrol?

Depo-Medrol is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for muscle weakness.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • 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...
  • Patients who agree to be a part of the study
  • Patients with lumbar disc degeneration
  • Patients between ages of 18 and 75

You likely can't join if

  • Scoliosis \>10°
  • Spondylolisthesis \>Grade 1
  • Flatback deformity
  • Patients with insulin dependent diabetes
  • Patients with \>3 levels of fusion
  • Alternative interbodies
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Farmington, Connecticut, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Farmington, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.