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Depo-Medrol on Psoas After LLIF

Primary Purpose

Muscle Weakness, Pain, Postoperative, Paresthesia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Depo-Medrol
Gel-Flow NT
Sponsored by
Hardeep Singh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Weakness focused on measuring lateral lumbar interbody fusion, LLIF, Depo-Medrol, corticosteroid, lumbar spine, psoas muscle, postoperative hip flexor weakness, postoperative thigh pain, postoperative thigh numbness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UConn HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group (standard care)

Test group (standard care + study intervention)

Arm Description

1 cc gel foam powder mixed with thrombin

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

Outcomes

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.
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.
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.
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.
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.
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)
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)
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
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.
Fusion rate - Assessed with Flexion, Extension X-ray (screw loosening/fracture, instability) CT Scan if patient has a symptomatic (pain) pseudoarthrosis (lack of fusion)

Full Information

First Posted
May 26, 2023
Last Updated
June 29, 2023
Sponsor
Hardeep Singh
Collaborators
Society for Minimally Invasive Spine Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05929755
Brief Title
Depo-Medrol on Psoas After LLIF
Official Title
Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hardeep Singh
Collaborators
Society for Minimally Invasive Spine Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Pain, Postoperative, Paresthesia, Pain, Muscle
Keywords
lateral lumbar interbody fusion, LLIF, Depo-Medrol, corticosteroid, lumbar spine, psoas muscle, postoperative hip flexor weakness, postoperative thigh pain, postoperative thigh numbness

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (standard care)
Arm Type
Placebo Comparator
Arm Description
1 cc gel foam powder mixed with thrombin
Arm Title
Test group (standard care + study intervention)
Arm Type
Experimental
Arm Description
1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol
Intervention Type
Drug
Intervention Name(s)
Depo-Medrol
Intervention Description
steroid
Intervention Type
Drug
Intervention Name(s)
Gel-Flow NT
Intervention Description
hemostatic agent
Primary Outcome Measure Information:
Title
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.
Description
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"?
Time Frame
2-3 weeks following surgery
Title
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.
Description
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"?
Time Frame
6 weeks following surgery
Title
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.
Description
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"?
Time Frame
12 weeks following surgery
Secondary Outcome Measure Information:
Title
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.
Description
Thigh numbness - binary: yes/no
Time Frame
6 months, 1 year, 2 years
Title
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.
Description
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
Time Frame
6 months, 1 year, 2 years
Title
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)
Description
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."
Time Frame
2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
Title
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Oswestry Disability Index (ODI)
Description
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).
Time Frame
2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
Title
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Sciatica Bothersomeness Index
Description
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.
Time Frame
2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
Title
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.
Description
Fusion rate - Assessed with Flexion, Extension X-ray (screw loosening/fracture, instability) CT Scan if patient has a symptomatic (pain) pseudoarthrosis (lack of fusion)
Time Frame
1 year and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hardeep Singh, MD
Phone
860-679-6883
Email
uconnorthopaedics@uchc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
860-679-6883
Email
uconnorthopaedics@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hardeep Singh, M.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Email
uconnorthopaedics@uchc.edu
First Name & Middle Initial & Last Name & Degree
Hardeep Singh, M.D.
First Name & Middle Initial & Last Name & Degree
Isaac Moss, M.D., C.M., M.A.Sc., FRCSC
First Name & Middle Initial & Last Name & Degree
Scott Mallozzi, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Depo-Medrol on Psoas After LLIF

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