Depo-Medrol on Psoas After LLIF

Hardeep Singh

Status and phase: Enrolling; Phase 4

Conditions: Pain, Muscle; Paresthesia; Muscle Weakness; Pain, Postoperative

Treatments: Drug: Depo-Medrol; Drug: Gel-Flow NT

Study type: Interventional

Funder types: Other

Identifiers

NCT05929755

23-090-2

Details and patient eligibility

About

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.

Full description

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.

• Quantity 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Control group (standard care)

Placebo Comparator group

Description:

1 cc gel foam powder mixed with thrombin

Treatment:

Drug: Gel-Flow NT

Test group (standard care + study intervention)

Experimental group

Description:

1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol

Treatment:

Drug: Gel-Flow NT

Drug: Depo-Medrol