NCT05929755

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
12mo left

Started May 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
May 2023May 2027

Study Start

First participant enrolled

May 12, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

May 26, 2023

Last Update Submit

July 18, 2025

Conditions

Muscle WeaknessPain, PostoperativeParesthesiaPain, Muscle

Keywords

lateral lumbar interbody fusionLLIFDepo-Medrolcorticosteroidlumbar spinepsoas musclepostoperative hip flexor weaknesspostoperative thigh painpostoperative thigh numbness

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (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.

    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.

    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)

    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)

    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

    2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years

  • +1 more secondary outcomes

Study Arms (2)

Control group (standard care)

PLACEBO COMPARATOR

1 cc gel foam powder mixed with thrombin

Drug: Gel-Flow NT

Test group (standard care + study intervention)

EXPERIMENTAL

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

Drug: Depo-MedrolDrug: Gel-Flow NT

Interventions

Depo-MedrolDRUG

steroid

Test group (standard care + study intervention)
Gel-Flow NTDRUG

hemostatic agent

Control group (standard care)Test group (standard care + study intervention)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

RECRUITING

MeSH Terms

Conditions

Muscle WeaknessPain, PostoperativeParesthesiaMyalgia

Interventions

Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPostoperative ComplicationsPainSomatosensory DisordersSensation DisordersNeuromuscular DiseasesMusculoskeletal Pain

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Hardeep Singh, M.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hardeep Singh, MD

CONTACT

860-679-6883uconnorthopaedics@uchc.edu

Study Coordinator

CONTACT

860-679-6883uconnorthopaedics@uchc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Orthopedic Surgery

Study Record Dates

First Submitted

May 26, 2023

First Posted

July 3, 2023

Study Start

May 12, 2023

Primary Completion

August 1, 2025

Study Completion (Estimated)

May 1, 2027

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)