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

NCT ID: NCT01763619

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-07-31

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.

Conditions

Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Freedom Cervical Disc

Group Type: EXPERIMENTAL

Freedom Cervical Disc

Intervention Type: DEVICE

Interventions

Freedom Cervical Disc

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AxioMed Spine Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitatsklinikum Bonn

Bonn, , Germany

Stadtisches Klinikum Gorlitz

Görlitz, , Germany

Stadtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Klinik St. Anna

Lucerne, , Switzerland

Spine Center Rischke

Zurich, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

PR-300

Identifier Type: -

Identifier Source: org_study_id