Overview

This trial is active, not recruiting.

Condition symptomatic cervical degenerative disc disease (ddd) from c3-c7
Treatment freedom cervical disc
Sponsor AxioMed Spine Corporation
Start date February 2013
End date July 2017
Trial size 50 participants
Trial identifier NCT01763619, PR-300

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
freedom cervical disc

Primary Outcomes

Measure
Safety of FCD
time frame: 6 months
Performance of FCD
time frame: 6 months

Secondary Outcomes

Measure
Incidence of AEs
time frame: 2 year
Neck/Arm Pain
time frame: 2 years
Neurological function
time frame: 2 years
Subject Function
time frame: 2 years
Radiographic Measurements
time frame: 2 years
Examine AEs
time frame: 2 years

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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

Additional Information

Official title Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AxioMed Spine Corporation.