Clinical trial NCT01763619: Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
Official title: Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7
Keywords: Cervical DDD
DDD
degenerative disc disease
C3-C7
Lead sponsor: AxioMed Spine Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety of FCD
timeFrame: 6 months
measure: Performance of FCD
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of AEs
timeFrame: 2 year
measure: Neck/Arm Pain
timeFrame: 2 years
measure: Neurological function
timeFrame: 2 years
measure: Subject Function
timeFrame: 2 years
measure: Radiographic Measurements
timeFrame: 2 years
measure: Examine AEs
timeFrame: 2 years
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Gorlitz
country: Germany
facility: Stadtisches Klinikum Gorlitz
city: Karlsruhe
country: Germany
facility: Stadtisches Klinikum Karlsruhe
city: Luzern
country: Switzerland
facility: Klinik St. Anna
city: Zurich
country: Switzerland
facility: Spine Center Rischke
Study officials:
References: