NCT05929755 Depo-Medrol on Psoas After LLIF
| NCT ID | NCT05929755 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hardeep Singh |
| Condition | Muscle Weakness |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-05-12 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2023-05-12 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Hardeep Singh, M.D.
PRINCIPAL INVESTIGATOR
UConn Health
Frequently Asked Questions
Who can join the NCT05929755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Muscle Weakness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05929755 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05929755 currently recruiting?
Yes, NCT05929755 is actively recruiting participants. Contact the research team at uconnorthopaedics@uchc.edu for enrollment information.
Where is the NCT05929755 trial being conducted?
This trial is being conducted at Farmington, United States.
Who is sponsoring the NCT05929755 clinical trial?
NCT05929755 is sponsored by Hardeep Singh. The principal investigator is Hardeep Singh, M.D. at UConn Health. The trial plans to enroll 80 participants.