Recruiting

Depo-Medrol

Sponsor:

Hardeep Singh

Code:

NCT05929755

Conditions

Muscle Weakness

Pain, Postoperative

Paresthesia

Pain, Muscle

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Depo-Medrol

Gel-Flow NT

Study Details

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.

Conditions

Muscle Weakness

Pain, Postoperative

Paresthesia

Pain, Muscle

Study ID

NCT05929755

Start date

May 12, 2023

Status verified date

Jul, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Control group (standard care)

1 cc gel foam powder mixed with thrombin

experimental: Test group (standard care + study intervention)

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

Interventions

Depo-Medrol

steroid

Gel-Flow NT

hemostatic agent

Primary 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. [ 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 ]

Central Contacts and Locations

Central contacts

Hardeep Singh, MD

860-679-6883uconnorthopaedics@uchc.edu

Study Coordinator

860-679-6883uconnorthopaedics@uchc.edu

Locations

UConn Health

Recruiting

Farmington, Connecticut, United States, 06030

Contacts

Study Coordinator

uconnorthopaedics@uchc.edu

Principal Investigator:

Hardeep Singh, M.D.

More Information

Sponsor

Hardeep Singh

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Keywords

  • lateral lumbar interbody fusion
  • LLIF
  • Depo-Medrol
  • corticosteroid
  • lumbar spine
  • psoas muscle
  • postoperative hip flexor weakness
  • postoperative thigh pain
  • postoperative thigh numbness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hardeep Singh on 2025-07-24.