Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease

This study is currently recruiting participants.
Verified April 2014 by AxioMed Spine Corporation
Sponsor:
Information provided by (Responsible Party):
AxioMed Spine Corporation
ClinicalTrials.gov Identifier:
NCT01763619
First received: January 4, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

This study will collect clinical and radiographic data on the Freedom Cervical Disc to monitor the device's safety and performance as part of a post-market evaluation.


Condition Intervention
Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7
Device: Freedom Cervical Disc

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease

Further study details as provided by AxioMed Spine Corporation:

Primary Outcome Measures:
  • Safety of FCD [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD.

  • Performance of FCD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period.


Secondary Outcome Measures:
  • Incidence of AEs [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    Examine the incidence of adverse events including device revision, removal or supplemental fixation through the 2-years post-operative period.

  • Neck/Arm Pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Examine changes in neck and arm pain throughout the 2-years post-operative period.

  • Neurological function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Examine changes in subject neurological function throughout the 2-years post-operative period.

  • Subject Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Examine changes in subject function throughout the 2-years post-operative period.

  • Radiographic Measurements [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Examine changes in radiographic measurements of the target, adjacent and cervical segment levels from discharge through the 2-years.

  • Examine AEs [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Examine all adverse events throughout the 2-years post-operative period


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Freedom Cervical Disc Device: Freedom Cervical Disc

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Skeletally mature males or females, aged 21 to 65 years old, inclusive.
  • Single, or adjacent, 2-level degenerative disc disease at C3-C7, inclusive.
  • Subject is a surgical candidate for an anterior approach to the cervical spine.
  • Minimum of 6 weeks of unsuccessful conservative treatment.
  • Subject with at least moderate preoperative pain and functional impairment
  • Subject is mentally and physically able to comply with protocol, postoperative compliance instructions, and follow-up schedule through 2-years.
  • Subject must understand and sign the written Informed Consent form.

Exclusion Criteria:

  • Subject with axial neck pain only who does not demonstrate concurrent arm pain or progressive neurological deterioration (specifically numbness or muscle weakness in the arm).
  • An active infection at the operative site or active systemic infection at the time of surgery.
  • Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
  • Previous spinal fusion at the involved, or adjacent, cervical level(s).
  • Congenital or acquired structural defect at the operative levels (s) or their immediately adjacent level(s).
  • Significant osteoporosis in the cervical spine.
  • The investigator should assess if the subject has any of the following conditions at the index or adjacent level(s) which excludes the subject from study participation:
  • Cervical facet degeneration of the involved C3-C7 levels.
  • Previous trauma to, or fusion in, the C3-C7 levels.
  • Cervical instability at the index level(s) on neutral lateral or flexion/extension x-rays.
  • Radiographic findings of a fused or total collapsed disc.
  • Significant global cervical kyphosis (≥15º on Cobb angle measurement) or significant reversal of lordosis.
  • Female of childbearing potential, pregnant, breast feeding, or interested in becoming pregnant in the next two years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763619

Contacts
Contact: Neal Defibaugh 2165875566 ndefibaugh@axiomed.com
Contact: Courtney Maguire 2165875566 cmaguire@axiomed.com

Locations
Germany
Universitatsklinikum Bonn Recruiting
Bonn, Germany, 53105
Contact: Robert Pflugmacher, MD         
Principal Investigator: Robert Pflugmacher, MD         
Stadtisches Klinikum Gorlitz Recruiting
Gorlitz, Germany, 02828
Contact: Marcus Eif, MD         
Principal Investigator: Marcus Eif, MD         
Stadtisches Klinikum Karlsruhe Recruiting
Karlsruhe, Germany, 76133
Contact: George Kiriyanthan, MD         
Principal Investigator: George Kiriyanthan, MD         
Switzerland
Klinik St. Anna Recruiting
Luzern, Switzerland, CH-6006
Contact: Oliver Hausmann, MD         
Principal Investigator: Oliver Hausmann, MD         
Spine Center Rischke Recruiting
Zurich, Switzerland, CH 8001
Contact: Burkhard Rischke, MD         
Principal Investigator: Burkhard Rischke, MD         
Sponsors and Collaborators
AxioMed Spine Corporation
  More Information

No publications provided

Responsible Party: AxioMed Spine Corporation
ClinicalTrials.gov Identifier: NCT01763619     History of Changes
Other Study ID Numbers: PR-300
Study First Received: January 4, 2013
Last Updated: April 23, 2014
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission

Keywords provided by AxioMed Spine Corporation:
Cervical DDD
DDD
degenerative disc disease
C3-C7

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disk Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 23, 2014