Depo-Medrol on Psoas After LLIF

Sponsor

Hardeep Singh (Other)

Overall Status

Recruiting

CT.gov ID

NCT05929755

Collaborator

Society for Minimally Invasive Spine Surgery (Other)

Enrollment

Location

Arms

47.6

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Weakness Pain, Postoperative Paresthesia Pain, Muscle	Drug: Depo-Medrol Drug: Gel-Flow NT	Phase 4

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 12, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Control group (standard care)

1 cc gel foam powder mixed with thrombin

Drug: Gel-Flow NT

hemostatic agent

Experimental: Test group (standard care + study intervention)

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

Drug: Depo-Medrol

steroid

Drug: Gel-Flow NT

hemostatic agent

Outcome Measures

Primary Outcome Measures

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. [2-3 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"?
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. [6 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"?
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. [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"?

Secondary Outcome Measures

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. [6 months, 1 year, 2 years]
Thigh numbness - binary: yes/no
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. [6 months, 1 year, 2 years]
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
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) [2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years]
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."
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Oswestry Disability Index (ODI) [2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years]
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).
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Sciatica Bothersomeness Index [2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years]
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.
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. [1 year and 2 years]
Fusion rate - Assessed with Flexion, Extension X-ray (screw loosening/fracture, instability) CT Scan if patient has a symptomatic (pain) pseudoarthrosis (lack of fusion)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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