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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Freedom Cervical Disc

About this trial

This is an interventional treatment trial for Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7 focused on measuring Cervical DDD, DDD, degenerative disc disease, C3-C7

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universitatsklinikum Bonn
Stadtisches Klinikum Gorlitz
Stadtisches Klinikum Karlsruhe
Klinik St. Anna
Spine Center Rischke

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Freedom Cervical Disc

Arm Description

Outcomes

Primary Outcome Measures

Safety of FCD

Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD.

Performance of FCD

Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period.

Secondary Outcome Measures

Incidence of AEs

Examine the incidence of adverse events including device revision, removal or supplemental fixation through the 2-years post-operative period.

Neck/Arm Pain

Examine changes in neck and arm pain throughout the 2-years post-operative period.

Neurological function

Examine changes in subject neurological function throughout the 2-years post-operative period.

Subject Function

Examine changes in subject function throughout the 2-years post-operative period.

Radiographic Measurements

Examine changes in radiographic measurements of the target, adjacent and cervical segment levels from discharge through the 2-years.

Examine AEs

Examine all adverse events throughout the 2-years post-operative period

Full Information

NCT ID

NCT01763619

First Posted

January 4, 2013

Last Updated

July 28, 2016

Sponsor

AxioMed Spine Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01763619

Brief Title

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

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AxioMed Spine Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Cervical DDD, DDD, degenerative disc disease, C3-C7

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Freedom Cervical Disc

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Freedom Cervical Disc

Primary Outcome Measure Information:

Title

Safety of FCD

Description

Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD.

Time Frame

6 months

Title

Performance of FCD

Description

Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Incidence of AEs

Description

Examine the incidence of adverse events including device revision, removal or supplemental fixation through the 2-years post-operative period.

Time Frame

2 year

Title

Neck/Arm Pain

Description

Examine changes in neck and arm pain throughout the 2-years post-operative period.

Time Frame

2 years

Title

Neurological function

Description

Examine changes in subject neurological function throughout the 2-years post-operative period.

Time Frame

2 years

Title

Subject Function

Description

Examine changes in subject function throughout the 2-years post-operative period.

Time Frame

2 years

Title

Radiographic Measurements

Description

Examine changes in radiographic measurements of the target, adjacent and cervical segment levels from discharge through the 2-years.

Time Frame

2 years

Title

Examine AEs

Description

Examine all adverse events throughout the 2-years post-operative period

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Universitatsklinikum Bonn

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Stadtisches Klinikum Gorlitz

City

Gorlitz

ZIP/Postal Code

02828

Country

Germany

Facility Name

Stadtisches Klinikum Karlsruhe

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

Klinik St. Anna

City

Luzern

ZIP/Postal Code

CH-6006

Country

Switzerland

Facility Name

Spine Center Rischke

City

Zurich

ZIP/Postal Code

CH 8001

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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