Neurosurgery Patient Outcomes in Treating Spinal Disorders (Neuropoint SD)

Greenwich Hospital

Status and phase: Completed; Phase 3

Conditions: Symptomatic Lumbar Disc Herniation; Symptomatic Grade I Lumbar Spondylolisthesis

Treatments: Procedure: Single-level lumbar fusion; Procedure: Lumbar Discectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01220921

Neuropoint SD

Details and patient eligibility

About

The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .

Enrollment: 198 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Grade I degenerative or isthmic spondylolisthesis recalcitrant to non-invasive therapies for at least 3 months or Lumbar degenerative disc herniation with radiculopathy refractory to non-invasive therapies for at least 6 weeks

Exclusion criteria

• History of previous lumbar spine surgery
• Significant motor weakness (3/5) (i.e. foot drop)
• Cancer, infection, or fracture
• Pregnancy

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Lumbar Microdiscectomy

Experimental group

Description:

Patients aged 18-80 with symptomatic lumbar disc herniation resulting in single nerve root compression recalcitrant to non-invasive therapies for at least 6 weeks

Treatment:

Procedure: Lumbar Discectomy

Single-Level Lumbar Fusion

Experimental group

Description:

Patients aged 18-80 with symptomatic grade I degenerative or isthmic spondylolisthesis with mechanical back pain with or without radiculopathy recalcitrant to non-invasive therapies for at least 3 months

Treatment:

Procedure: Single-level lumbar fusion