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

NCT ID: NCT01652053

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2018-06-30

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.

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

Keywords

InterCushion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Disc Nucleus Replacement

Disc Nucleus Replacement (InterCushion DNP)

Disc Nucleus Replacement (InterCushion DNP)

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Other Intervention Names

InterCushion Disc Nucleus Prosthesis (DNP)

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertebral Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phillip F de Muelanaere, MD

Role: PRINCIPAL_INVESTIGATOR

Brandon General Hospital

Locations

Brandon Regional Health Center

Brandon, Manitoba, Canada

Site Status: RECRUITING

Countries

United States; Canada

Central Contacts

Laurie E Lynch, PhD

Role: CONTACT

Phone: 952-221-2468

Email: laurie.lynch@visi.com

Felt Jeff, MD

Role: CONTACT

Phone: 612-708-4838

Email: jfelt@vti-spine.com

Facility Contacts

Jeff Felt, MD

Role: primary

Ben A. Wasscher, MBA

Role: backup

Other Identifiers

CP 2010-001

Identifier Type: -

Identifier Source: org_study_id