Use of Local Intraoperative Steroid in MIS TLIF

NCT03308084 | Completed Phase 3

• 1 other identifier: 15052003
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already currently used at Rush and are considered standard of practice. It is well established that steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is routinely used in many types of surgery, but it is not known whether two steroids are better than one. The medications provided in this study are approved by the Food and Drug Administration (FDA).

Conditions

Dysphasia

Keywords

transforaminal lumbar interbody fusion, methylprednisolone

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed

  2 years postoperative

Secondary Outcomes (7)

• Physical Functioning

  2 years postoperative

• Disability

  2 years postoperative

• General health status

  2 years postoperative

• Narcotic Consumption

  1 week postoperative

• Length of Stay

  1 week postoperative

Study Arms (2)

Local Depomedrol plus IV dexamethasone

ACTIVE COMPARATOR

Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone

Drug: Methylprednisolone; Drug: Dexamethasone

IV dexamethasone

PLACEBO COMPARATOR

Standard systemic (IV) dexamethasone only

Drug: Dexamethasone

Interventions

Methylprednisolone DRUG

Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure

Local Depomedrol plus IV dexamethasone

Dexamethasone DRUG

Administration of 10mg Dexamethasone IV intraoperatively

IV dexamethasone; Local Depomedrol plus IV dexamethasone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a primary 1- to 2-level MIS TLIF
• Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
• Patients able to provide informed consent

You may not qualify if:

• Allergies or other contraindications to medicines in the protocol including:
• (a) Existing history of gastrointestinal bleeding
• Current Smokers
• Lumbar spine trauma
• Bilateral cages
• Lack of consent

Sponsors & Collaborators

• Rush University Medical Center: lead

Related Publications (6)

• Schizas C, Tzinieris N, Tsiridis E, Kosmopoulos V. Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience. Int Orthop. 2009 Dec;33(6):1683-8. doi: 10.1007/s00264-008-0687-8. Epub 2008 Nov 21.

  PMID: 19023571 BACKGROUND

• McGirt MJ, Parker SL, Lerner J, Engelhart L, Knight T, Wang MY. Comparative analysis of perioperative surgical site infection after minimally invasive versus open posterior/transforaminal lumbar interbody fusion: analysis of hospital billing and discharge data from 5170 patients. J Neurosurg Spine. 2011 Jun;14(6):771-8. doi: 10.3171/2011.1.SPINE10571. Epub 2011 Mar 18.

  PMID: 21417699 BACKGROUND

• Ranguis SC, Li D, Webster AC. Perioperative epidural steroids for lumbar spine surgery in degenerative spinal disease. A review. J Neurosurg Spine. 2010 Dec;13(6):745-57. doi: 10.3171/2010.6.SPINE09796.

  PMID: 21121754 BACKGROUND

• Jamjoom BA, Jamjoom AB. Efficacy of intraoperative epidural steroids in lumbar discectomy: a systematic review. BMC Musculoskelet Disord. 2014 May 5;15:146. doi: 10.1186/1471-2474-15-146.

  PMID: 24885519 BACKGROUND

• Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6. doi: 10.1097/00024720-200208000-00002.

  PMID: 12177541 BACKGROUND

• Haws BE, Khechen B, Patel DV, Bawa MS, Ahn J, Bohl DD, Mayo BC, Massel DH, Guntin JA, Cardinal KL, Singh K. Impact of local steroid application in a minimally invasive transforaminal lumbar interbody fusion: results of a prospective, randomized, single-blind trial. J Neurosurg Spine. 2018 Nov 9;30(2):222-227. doi: 10.3171/2018.7.SPINE18584. Print 2019 Feb 1.

  PMID: 30497132 DERIVED

MeSH Terms

Conditions

Aphasia

Interventions

Methylprednisolone; Dexamethasone

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Kern Singh, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 12, 2017
• Study Start: November 13, 2015
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share