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

NCT01652053 | Unknown

• 1 other identifier: CP 2010-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

InterCushion

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Maintenance or decrease in ODI

  12 and 24 months

• Maintenance or decrease in VAS

  12 and 24 months

• Maintenance of post-operative disc height.

  12 and 24 months

• Mobility of treated segment

  12 and 24 months

• Neurological deficits

  12 and 24 months

Other Outcomes (1)

• Failures

  6, 12 and 24 months

Study Arms (1)

Disc Nucleus Replacement

Disc Nucleus Replacement (InterCushion DNP)

Device: Disc Nucleus Replacement (InterCushion DNP)

Interventions

Disc Nucleus Replacement (InterCushion DNP) 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.

Also known as: InterCushion Disc Nucleus Prosthesis (DNP)

Disc Nucleus Replacement

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vertebral Technologies, Inc.: lead

Study Sites (1)

Brandon Regional Health Center

Brandon, Manitoba, R7A 2B3, Canada

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Phillip F de Muelanaere, MD

  Brandon General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie E Lynch, PhD

CONTACT

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

Felt Jeff, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 27, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)