Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2023-05-12
2027-05-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Control group (standard care)
1 cc gel foam powder mixed with thrombin
Gel-Flow NT
hemostatic agent
Test group (standard care + study intervention)
1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol
Depo-Medrol
steroid
Gel-Flow NT
hemostatic agent
Interventions
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Depo-Medrol
steroid
Gel-Flow NT
hemostatic agent
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Society for Minimally Invasive Spine Surgery
OTHER
Hardeep Singh
OTHER
Responsible Party
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Hardeep Singh
Assistant Professor of Orthopedic Surgery
Principal Investigators
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Hardeep Singh, M.D.
Role: PRINCIPAL_INVESTIGATOR
UConn Health
Locations
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UConn Health
Farmington, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-090-2
Identifier Type: -
Identifier Source: org_study_id
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