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

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.

Study Overview

• Status: Unknown
• Conditions: Disk, Herniated
• Intervention / Treatment: Device: Disc Nucleus Replacement (InterCushion 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).

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Laurie E Lynch, PhD; Phone Number: 952-221-2468; Email: laurie.lynch@visi.com
• Study Contact Backup: Name: Felt Jeff, MD; Phone Number: 612-708-4838; Email: jfelt@vti-spine.com

Study Locations

• Canada
  • Manitoba
    • Brandon, Manitoba, Canada, R7A 2B3
      • Recruiting
      • Brandon Regional Health Center
      • Contact: Jeff Felt, MD; Phone Number: 612-708-4838; Email: jfelt@vti-spine.com
      • Contact: Ben A. Wasscher, MBA; Phone Number: 763-218-4311; Email: bwasscher@vti-spine.com
      • Principal Investigator: Phillip de Mueleneare, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Disc Nucleus Replacement; Disc Nucleus Replacement (InterCushion DNP)	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.; Other Names: InterCushion Disc Nucleus Prosthesis (DNP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in ODI	Improvement in the Oswestry Disability Index (ODI) score i.e. decrease of 15% or better ODI.	6 months
Decrease in VAS	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)	6 months
Maintenance of post-operative disc height	Disc at the treated level is collapsed by ≤ 15% when compared to an adjacent health level.	6 months
Mobility of treated segment	Motion of ≥ 3 degrees on lateral flexion/extension radiographs	6 months
Neurologic deficits	No new permanent neurological deficit or worsening of an existing permanent neurological deficit	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance or decrease in ODI	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.	12 and 24 months
Maintenance or decrease in VAS	Maintenance of improvement or further improvement in leg pain evidenced by decrease in pain score on the visual analog scale (VAS)	12 and 24 months
Maintenance of post-operative disc height.	Disc at the treated level is collapsed by ≤ 15% when compared to an adjacent health level.	12 and 24 months
Mobility of treated segment	Motion of ≥ 3 degrees on lateral flexion/extension radiographs	12 and 24 months
Neurological deficits	No new permanent neurological deficit or worsening of an existing permanent neurological deficit	12 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failures	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.	6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Vertebral Technologies, Inc.
• Investigators: Principal Investigator: Phillip F de Muelanaere, MD, Brandon General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: InterCushion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: CP 2010-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO