Depo-Medrol on Psoas After LLIF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Depo-Medrol, Gel-Flow NT.
- Who it may be relevant to
- Registry conditions: Muscle Weakness, Pain, Postoperative, Paresthesia, Pain, Muscle. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness
Overview
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
Interventions
- Drug Depo-Medrol
steroid - Drug Gel-Flow NT
hemostatic agent
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. [Time frame: 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. [Time frame: 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. [Time frame: 12 weeks following surgery]
Secondary outcome measures (6)
- 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. [Time frame: 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. [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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. [Time frame: 1 year and 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- UConn Health — Farmington
Identifiers
NCT: NCT05929755 · 23-090-2