Depo-Medrol on Psoas After LLIF

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Muscle Weakness, Pain, Postoperative, Paresthesia, Pain, Muscle

Intervention / Treatment
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* Drug: Depo-Medrol
* Drug: Gel-Flow NT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group (standard care)<br>1 cc gel foam powder mixed with thrombin | Drug: Gel-Flow NT<br>* hemostatic agent<br>|
| Experimental: Test group (standard care + study intervention)<br>1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol | Drug: Depo-Medrol<br>* steroid<br>Drug: Gel-Flow NT<br>* hemostatic agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from no pain to worst pain imaginable? | 2-3 weeks following surgery | 
| 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. | Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from no pain to worst pain imaginable? | 6 weeks following surgery | 
| 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. | Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from no pain to worst pain imaginable? | 12 weeks following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the difference in rates of postoperative thigh 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. | Thigh numbness - binary: yes/no | 6 months, 1 year, 2 years | 
| Quantify the difference in severity of postoperative hip flexor weakness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection. | Hip flexion strength measured via graded exam: the Medical Research Council Manual Muscle Testing scale. This method involves testing key muscles from the lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: 0 No muscle activation Trace muscle activation, such as a twitch, without achieving full range of motion Muscle activation with gravity eliminated, achieving full range of motion Muscle activation against gravity, full range of motion Muscle activation against some resistance, full range of motion Muscle activation against examiner's full resistance, full range of motion | 6 months, 1 year, 2 years | 
| Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Euro-Quality of Life 5 dimension questionnaire (EQ5D) | The Euro-Quality of Life 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems through extreme problems. | 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years | 
| Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is an outcome measure that was designed to assess function in activities of daily living for those with acute or chronic back pain. The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability). | 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years | 
| Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Sciatica Bothersomeness Index | Sciatica Bothersomeness index includes self-reported ratings of symptom intensity of: Leg pain Numbness or tingling in the leg, foot or groin Weakness in the leg/foot Back or leg pain while sitting Each symptom item is rated on a scale from 0 to 6, with 0 being not bothersome, 3 somewhat bothersome and 6 extremely bothersome. | 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years | 
| 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. | Fusion rate - Assessed with Flexion, Extension X-ray (screw loosening/fracture, instability) CT Scan if patient has a symptomatic (pain) pseudoarthrosis (lack of fusion) | 1 year and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lateral lumbar interbody fusion, LLIF, Depo-Medrol, corticosteroid, lumbar spine, psoas muscle, postoperative hip flexor weakness, postoperative thigh pain, postoperative thigh numbness