Freedom® Cervical Disc Use In The Treatment of Cervical D... | NCT01763619

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

NCT01763619

Sponsor

AxioMed Spine Corporation

Status

Unknown status

Last Update Posted

Jul 29, 2016Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

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

Interventions

Freedom Cervical Disc

Countries

Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jul 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Jan 4, 2013

First Submission Date that Met QC Criteria

Jan 7, 2013

First Posted Date

Jan 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2016

Last Update Posted Date

Jul 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Freedom Cervical Disc	Experimental		Device: Freedom Cervical Disc

Name	Type	Description	Arm Group Labels	Other Names
Freedom Cervical Disc	Device		Freedom Cervical Disc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of FCD	Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD.	6 months
Performance of FCD	Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of AEs	Examine the incidence of adverse events including device revision, removal or supplemental fixation through the 2-years post-operative period.	2 year
Neck/Arm Pain	Examine changes in neck and arm pain throughout the 2-years post-operative period.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Universitatsklinikum Bonn		Bonn		53105	Germany
Stadtisches Klinikum Gorlitz

ID	Term
C562924	Dowling-Degos Disease
D055959	Intervertebral Disc Degeneration

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases