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Clinical Trial Details
Effect of Depo-Medrol application on the psoas muscle after transpsoas LLIF on post-operative hip flexor weakness, thigh pain and numbness.
Clinical Trial ( IRB ) #: 23-090-2
Title: Effect of Depo-Medrol application on the psoas muscle after transpsoas LLIF on post-operative hip flexor weakness, thigh pain and numbness.
Principal Investigator: Dr. Hardeep Singh
Description: Goal: The goal of this study is to determine the effects of a corticosteroid adminstired to the psoas muscle following a transpsoas LLIF on postoperative hip flexor weakness and thigh pain and numbness. Specific Objectives Primary Objective and Outcome Measure: Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery. Secondary Objectives and Outcome Measures: Quantify the difference in rates and severity of postoperative hip flexor weakness, and numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection. Quantify patient reported outcomes measures (PROMs) (EQ5D, ODI, and sciatica Bothersome index between those that did and did not receive a depo-medrol injection. Specifically: EQ5D: Eur-Quality of Life 5 dimension questionnaire ODI: Oswestry Disability Index Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection. Ancillary Objectives and Outcome Measures: To determine the effect of clinically relevant covariates including sociodemographic and comorbidities on the course of postoperative pain and associated outcome measures and whether the effect of these covariates moderate the effect of postoperative pain. Groups: Control group (standard care) - 1cc gel foam powder mixed with thrombin Steroid group (standard care + study intervention) - 1cc gel foam powder mixed with thrombin and 80mg depomedrol
Classification:
  Muscle, Bone and Cartilage
  Pain
Eligibility Criteria: Check with study contact
How to Contact: Joellen Broska. Telephone: 860-679-6019. Email: broska@uchc.edu or Kelly Rushlow. Telephone 860-679-7664. Email: rushlow@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.