Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness

23-090-2

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.

2023-05-12

2025-08-01

2027-05-01

Recruiting

Early phase I

80

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2023-07-03