Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

Rush

Status and phase: Withdrawn; Phase 3

Conditions: Degenerative Disc Disease; Radiculopathy; Myeloradiculopathy; Myelopathy; Herniated Nucleus Pulposus; Spondylosis; Stenosis

Treatments: Drug: Saline; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03327272

17102301

Details and patient eligibility

About

Neural injury is a well-known complication following extreme lateral lumbar interbody fusion (XLIF). It has been found that up to 9.4% of patients will have either temporary or persistent neurologic deficit. This occurs with traversal of the psoas muscle or direct injury to lumbosacral plexus or sympathetic ganglion. While often temporary, it can cause hip flexor weakness, thigh numbness, or pain.

Several studies have demonstrated reduced patient reported pain scores following steroid administration, particularly in the early postoperative period. However, few studies have investigated the efficacy of intraoperative local injection of corticosteroid in reducing the incidence and duration of postoperative pain or neurologic injury for XLIF patients.

Full description

The purpose of this study is to determine if the incidence and duration of postoperative pain is reduced in the subjects receiving a local injection of methylprednisolone when compared to placebo following XLIF.

The investigators hypothesize that subjects undergoing XLIF who receive local methylprednisolone will have:

1. Reduced incidence and duration of postoperative pain and neurologic injury
2. Shorter hospital stay
3. Better short- and long-term outcomes

The study also aims to answer the following questions:

1. Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo?
2. Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo?
3. Is local corticosteroid therapy associated with improved short and long-term outcomes?

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Allergies or other contraindications to medicines in the protocol including:
• Existing history of gastrointestinal bleeding
• Lumbar spine trauma
• Unable to speak, read, or understand English

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Local injection of methylprednisolone

Active Comparator group

Description:

Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure

Treatment:

Drug: Methylprednisolone

Local injection of saline

Placebo Comparator group

Description:

Administration of saline at surgical site prior to incision closure.

Treatment:

Drug: Saline