A Prospective, Multicenter Study Investigating Reherniation Risk Factors and Associated Costs in Primary Lumbar Disc Herniation Patients
The purpose of this 12-month, prospective, multicenter study is to investigate the effect of annular defect size and other risk factors on reherniation and associated costs in primary lumbar discectomy patients.
• Age 21 to 75 years old and skeletally mature (male or female).
• Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using MRI. \[Note: Intraoperatively, only patients with an annular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.\]
• Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)22 (L45, L5S1) or Femoral Stretch Test (L12, L23, L34)
• Oswestry Questionnaire score of at least 40/100 at baseline.
• VAS leg pain (one or both legs) of at least 40/100 at baseline.
• Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
• Minimum posterior disc height of 5mm at the index level.