Recruiting

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

Sponsor:

Vertebral Technologies, Inc.

Code:

NCT01652053

Conditions

Disk, Herniated

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Interventions

Disc Nucleus Replacement (InterCushion DNP)

Study Details

Brief 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.

Conditions

Disk, Herniated

Study ID

NCT01652053

Start date

Jan, 2012

Status verified date

Nov, 2016

Completion date

Jun, 2018

Anticipated

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patient has signed and dated a study specific informed consent form approved by the reviewing Institutional Review Board or Ethics Committee.
Patient is 21 to 60 years of age.
Patient is skeletally mature
Patient requires a discectomy of one level from L2-S1.
Patient has less than 50% loss of disc height at the affected level.
Patient has persistent pain (predominantly leg pain, although some back pain that occurred at the same time as the leg pain and is believed to be associated with the disc herniation will not disqualify the patient from participating in this study) and symptoms despite a minimum of six weeks of non-operative treatment.
Patient X-ray, CT or MR evidence of a herniated disc at the affected level.
Patient has a minimum leg pain score of 6 cm on a 10 cm (i.e. 60 mm on a 100 mm) point visual analog scale (VAS).
Patient has a minimum Oswestry Disability Index score of 40% (based upon a 100% scale).
Patient is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

Patient has had any previous surgery at the affected levels.
Patient has had any attempt at spinal fusion, at any lumbar levels.
Patient has motion of < 3 degrees on pre-operative lateral flexion/extension radiographs
Patient has a BMI
Patient has severe osteoporosis of the spine.
Patient has previously undergone chemotherapy, immunosuppressive therapy or radiation to the local area.
Patient has active local or systemic infection.
Patient has any known active malignancy.
Patient has rheumatoid arthritis or systemic lupus erythematosus, or other chronic, inflammatory autoimmune disorder.
Patient has ankylosing spondylitis or other spondyloarthropathy.
Patient has spondylolisthesis.
Patient is pregnant or plans to become pregnant during the course of the study.
Patient has other concurrent physical or mental conditions that are likely to affect their outcome.
Patient has congenital stenosis
Patient is diabetic.
The patient has osteoporosis or severe osteopenia as determined by the Investigator. Females over 40 with bone density score less than -1. A clinical SCORE calculator may also be utilized for females over 40 years of age.
Patient has significant facet disease.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Disc Nucleus Replacement

Disc Nucleus Replacement (InterCushion DNP)

Interventions

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.

Primary outcome measure

Decrease in ODI [ Time Frame: 6 months ]
Decrease in VAS [ Time Frame: 6 months ]
Maintenance of post-operative disc height [ Time Frame: 6 months ]
Mobility of treated segment [ Time Frame: 6 months ]
Neurologic deficits [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Laurie E Lynch, PhD

952-221-2468 laurie.lynch@visi.com

Felt Jeff, MD

612-708-4838 jfelt@vti-spine.com

Locations

Brandon Regional Health Center

Recruiting

Brandon, Manitoba, Canada, R7A 2B3

Contacts

Jeff Felt, MD

612-708-4838 jfelt@vti-spine.com

Ben A. Wasscher, MBA

763-218-4311 bwasscher@vti-spine.com

Principal Investigator:

Phillip de Mueleneare, MD

More Information

Sponsor

Vertebral Technologies, Inc.

Last update posted

Nov 2, 2016

Last verified

Nov, 2016

Keywords

InterCushion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vertebral Technologies, Inc. on 2016-11-02.