Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Vertebral Technologies, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vertebral Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01652053
First received: July 24, 2012
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Disk, Herniated
Device: Spinal arthroplasty for disc herniation (InterCushion Disc Nucleus Prosthesis)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Clinical Study to Assess the Safety and Effectiveness of the InterCushion Disc Nucleus Prosthesis in Patients Receiving Discectomy

Further study details as provided by Vertebral Technologies, Inc.:

Primary Outcome Measures:
  • Decrease in ODI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in the Oswestry Disability Index (ODI) score i.e. decrease of 15% or better ODI.

  • Decrease in VAS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in leg pain evidenced by decrease in pain score of at least 2 cm (i.e. 20 mm) on the visual analog scale (VAS)

  • Maintenance of post-operative disc height [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Disc at the treated level is collapsed by ≤ 15% when compared to an adjacent health level.

  • Mobility of treated segment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Motion of ≥ 3 degrees on lateral flexion/extension radiographs

  • Neurologic deficits [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    No new permanent neurological deficit or worsening of an existing permanent neurological deficit


Secondary Outcome Measures:
  • Maintenance or decrease in ODI [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Maintenance of improvement or further improvement in the Oswestry Disability Index (ODI) score measured at six months i.e. decrease of 15% or better ODI.

  • Maintenance or decrease in VAS [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Maintenance of improvement or further improvement in leg pain evidenced by decrease in pain score on the visual analog scale (VAS)

  • Maintenance of post-operative disc height. [ Time Frame: 12 and 24 monts ] [ Designated as safety issue: No ]
    Disc at the treated level is collapsed by ≤ 15% when compared to an adjacent health level.

  • Mobility of treated segment [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Motion of ≥ 3 degrees on lateral flexion/extension radiographs

  • Neurological deficits [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
    No new permanent neurological deficit or worsening of an existing permanent neurological deficit


Other Outcome Measures:
  • Failures [ Time Frame: 6, 12 and 24 monhts ] [ Designated as safety issue: No ]

    Revision: is a procedure that adjusts or in any way modifies or removes part of the original implant configuration, with or without replacement of a component.

    Removal: is a procedure where the entire original system configuration is removed with or without replacement.

    Supplemental fixation: a procedure in which additional instrumentation not under study is implanted.



Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spinal arthroplasty for disc herniation
InterCushion DNP
Device: Spinal arthroplasty for disc herniation (InterCushion Disc Nucleus Prosthesis)
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.
Other Name: InterCushion Disc Nucleus Prosthesis (DNP)

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).

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652053

Contacts
Contact: Laurie E Lynch, PhD 952-221-2468 laurie.lynch@visi.com
Contact: Suresh Ghai, PhD 952-979-9357 sghai@vti-spine.com

Locations
United States, Minnesota
Verterbral Technologies, Inc. Recruiting
Minnetonka, Minnesota, United States, 55345
Contact: Suresh Ghai, PhD    952-979-9357    sghai@vti-spine.com   
Principal Investigator: Phillip de Mueleneare, MD         
Sponsors and Collaborators
Vertebral Technologies, Inc.
Investigators
Principal Investigator: Phillip F de Muelanaere, MD Brandon General Hospital
  More Information

No publications provided

Responsible Party: Vertebral Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01652053     History of Changes
Other Study ID Numbers: CP 2010-001
Study First Received: July 24, 2012
Last Updated: July 26, 2012
Health Authority: Canada: Health Canada

Keywords provided by Vertebral Technologies, Inc.:
InterCushion

ClinicalTrials.gov processed this record on November 23, 2014