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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AxioMed Spine Corporation Identifier:
First received: January 4, 2013
Last updated: July 28, 2016
Last verified: July 2016
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: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Freedom Cervical Disc Device: Freedom Cervical Disc


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01763619

Universitatsklinikum Bonn
Bonn, Germany, 53105
Stadtisches Klinikum Gorlitz
Gorlitz, Germany, 02828
Stadtisches Klinikum Karlsruhe
Karlsruhe, Germany, 76133
Klinik St. Anna
Luzern, Switzerland, CH-6006
Spine Center Rischke
Zurich, Switzerland, CH 8001
Sponsors and Collaborators
AxioMed Spine Corporation
  More Information

Responsible Party: AxioMed Spine Corporation Identifier: NCT01763619     History of Changes
Other Study ID Numbers: PR-300 
Study First Received: January 4, 2013
Last Updated: July 28, 2016
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission

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

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases processed this record on October 21, 2016