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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01763619
Recruitment Status : Unknown
Verified July 2016 by AxioMed Spine Corporation.
Recruitment status was:  Active, not recruiting
First Posted : January 9, 2013
Last Update Posted : July 29, 2016
Information provided by (Responsible Party):
AxioMed Spine Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7 Device: Freedom Cervical Disc Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
Study Start Date : February 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Freedom Cervical Disc Device: Freedom Cervical Disc

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

  2. Performance of FCD [ Time Frame: 6 months ]
    Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period.

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

  2. Neck/Arm Pain [ Time Frame: 2 years ]
    Examine changes in neck and arm pain throughout the 2-years post-operative period.

  3. Neurological function [ Time Frame: 2 years ]
    Examine changes in subject neurological function throughout the 2-years post-operative period.

  4. Subject Function [ Time Frame: 2 years ]
    Examine changes in subject function throughout the 2-years post-operative period.

  5. Radiographic Measurements [ Time Frame: 2 years ]
    Examine changes in radiographic measurements of the target, adjacent and cervical segment levels from discharge through the 2-years.

  6. Examine AEs [ Time Frame: 2 years ]
    Examine all adverse events throughout the 2-years post-operative period

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01763619

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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
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Responsible Party: AxioMed Spine Corporation Identifier: NCT01763619    
Other Study ID Numbers: PR-300
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by AxioMed Spine Corporation:
Cervical DDD
degenerative disc disease
Additional relevant MeSH terms:
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Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases