Clinical trial NCT01652053: A Pilot Study of the InterCushion Disc Nucleus Prosthesis (DNP) in Patients Receiving Discectomy
Official title: A Pilot Clinical Study to Assess the Safety and Effectiveness of the InterCushion Disc Nucleus Prosthesis in Patients Receiving Discectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disk, Herniated
Keywords: InterCushion
Lead sponsor: Vertebral Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The protocol includes skeletally mature patients, both male and female, 18 to 60 years old suffering from a herniated disc (confirmed by X-ray, CT or MRI) with persistent leg pain.

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).

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.

Primary outcomes:
measure: Decrease in ODI
timeFrame: 6 months
measure: Decrease in VAS
timeFrame: 6 months
measure: Maintenance of post-operative disc height
timeFrame: 6 months
measure: Mobility of treated segment
timeFrame: 6 months
measure: Neurologic deficits
timeFrame: 6 months
Secondary outcomes:
measure: Maintenance or decrease in ODI
timeFrame: 12 and 24 months
measure: Maintenance or decrease in VAS
timeFrame: 12 and 24 months
measure: Maintenance of post-operative disc height.
timeFrame: 12 and 24 months
measure: Mobility of treated segment
timeFrame: 12 and 24 months
measure: Neurological deficits
timeFrame: 12 and 24 months
Other outcomes:
measure: Failures
timeFrame: 6, 12 and 24 months
Locations:
city: Brandon
country: Canada
facility: Brandon Regional Health Center
state: Manitoba
Study officials:
affiliation: Brandon General Hospital
name: Phillip F de Muelanaere, MD
role: PRINCIPAL_INVESTIGATOR
References: