Clinical trial NCT05929755: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: 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
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Society for Minimally Invasive Spine Surgery
First posted: 2023-07-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
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.
timeFrame: 2-3 weeks following surgery
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.
timeFrame: 6 weeks following surgery
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.
timeFrame: 12 weeks following surgery
Secondary outcomes:
measure: 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.
timeFrame: 6 months, 1 year, 2 years
measure: 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.
timeFrame: 6 months, 1 year, 2 years
measure: 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)
timeFrame: 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
measure: Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Oswestry Disability Index (ODI)
timeFrame: 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
measure: Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Sciatica Bothersomeness Index
timeFrame: 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
measure: 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.
timeFrame: 1 year and 2 years
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Hardeep Singh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: