NCT01652053

A Pilot Study of the InterCushion Disc Nucleus Prosthesis (DNP) in Patients Receiving Discectomy

A Pilot Clinical Study to Assess the Safety and Effectiveness of the InterCushion Disc Nucleus Prosthesis in Patients Receiving Discectomy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Vertebral Technologies, Inc. · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary endpoints of the investigation will include assessment of the maintenance of disc height demonstrated by radiographic evidence based on plain radiographs and MRI and relief of pain as measured by Visual Analog Scale (VAS) at six months post-surgery. It is anticipated that outcomes with the InterCushion Disc Nucleus Prosthesis (DNP) will be comparable to or better than the historical published results for discectomy alone.

Detailed description

All patients will be followed for at least 24 months once enrolled in the study. Clinical evaluations will be conducted before surgery (baseline), intraoperative, 2 week (± 1 week), 6 week (± 1 week), 3 months (± 2 weeks), 6 months (± 1 month), 12 months (± 2 months) and 24 months (± 2 months).

Conditions

• Disk, Herniated

Interventions

Type	Name	Description
DEVICE	Disc Nucleus Replacement (InterCushion DNP)	The device is intended for spinal arthroplasty in skeletally mature patients with leg pain due to a herniated disc with or without back pain, who are having a discectomy at one level from L2 -S1. These patients should have no spondylolisthesis at the involved level.

Timeline

• Start date: 2012-01-01
• Primary completion: 2018-01-01
• Completion: 2018-06-01
• First posted: 2012-07-27
• Last updated: 2016-11-02

Locations

1 site across 1 country: Canada