Actively Recruiting
Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness
Led by Hardeep Singh · Updated on 2025-07-24
80
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
H
Hardeep Singh
Lead Sponsor
S
Society for Minimally Invasive Spine Surgery
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a corticosteroid called Depo-Medrol when applied to the psoas muscle after a transpsoas lateral lumbar interbody fusion (LLIF) surgery. The study aims to understand how this steroid impacts postoperative hip flexor weakness, thigh pain, and numbness. This is a Phase 4 randomized trial comparing standard care with and without Depo-Medrol application. Participants are divided into two groups: a control group receiving a gel foam powder mixed with thrombin, and a steroid group receiving the same gel foam combined with 80 mg of Depo-Medrol. The intervention is applied during surgery to the psoas muscle. The study measures outcomes at multiple times after surgery, including 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years, to assess pain, weakness, numbness, patient-reported quality of life, disability, sciatica symptoms, and fusion rates. Throughout the study, participants will have their thigh pain measured using a visual analog scale at early postoperative periods. Researchers will also evaluate hip flexor weakness and numbness severity, along with patient-reported outcome questionnaires such as the Euro-Quality of Life 5 dimension (EQ5D), Oswestry Disability Index (ODI), and Sciatica Bothersomeness Index. Fusion success will be assessed at 1 and 2 years. Follow-up visits monitor safety and functional recovery over two years after surgery.
CONDITIONS
Brief Title
Depo-Medrol on Psoas After LLIF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients from the practices of Drs. Singh, Mallozzi, Moss
- Transpsoas (PTP or LTP) lateral lumbar interbody fusion (LLIF) involving 1 to 3 disc levels including L3-4 and/or L4-5 with posterior instrumentation
- Patients who agree to participate in the study
- Patients diagnosed with lumbar disc degeneration
- Patients between 18 and 75 years old
You will not qualify if you...
- Scoliosis greater than 10 degrees
- Spondylolisthesis greater than Grade 1
- Flatback deformity
- Insulin dependent diabetes
- Fusion involving more than 3 levels
- Use of alternative interbodies
- Chronic oral steroid users
- Allergy or intolerance to Depo-Medrol or other steroids
- Requirement for bilateral transpsoas approaches
- Ipsilateral symptomatic hip pathology
- Revision fusion surgeries
- Cases involving trauma, tumor, or infection
- Patients unable to provide consent
- Non-fluent English speakers
- Patients lost to follow-up before the two-year follow-up period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 1 day
Participants undergo lateral lumbar interbody fusion surgery with posterior instrumentation and receive either standard care or standard care plus Depo-Medrol application to the psoas muscle.
Surgery day with immediate post-operative monitoring
Duration - Up to 12 weeks
Participants are followed to assess thigh pain, hip flexor weakness, numbness, and patient-reported outcomes at multiple time points after surgery.
Visits at 2-3 weeks, 6 weeks, and 12 weeks following surgery
Duration - Up to 2 years
Participants are monitored for long-term outcomes including postoperative thigh numbness, hip flexor weakness, fusion rates, and patient-reported outcomes over two years after surgery.
Visits at 6 months, 1 year, and 2 years following surgery
Trial Site Locations
Total: 1 location
1
UConn Health
Farmington, Connecticut, United States, 06030
Actively Recruiting
Research Team
H
Hardeep Singh, MD
S
Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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