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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 Disc Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014