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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05929755
Other study ID # 23-090-2
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 12, 2023
Est. completion date May 2027

Study information

Verified date June 2023
Source UConn Health
Contact Hardeep Singh, MD
Phone 860-679-6883
Email uconnorthopaedics@uchc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date May 2027
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
Depo-Medrol
steroid
Gel-Flow NT
hemostatic agent

Locations

Country Name City State
United States UConn Health Farmington Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Hardeep Singh Society for Minimally Invasive Spine Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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