NCT01763619

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

4.4 years

First QC Date

January 4, 2013

Last Update Submit

July 28, 2016

Conditions

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

Keywords

Cervical DDDDDDdegenerative disc diseaseC3-C7

Outcome Measures

Primary Outcomes (2)

  • 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 (6)

  • Incidence of AEs

    2 year

  • Neck/Arm Pain

    2 years

  • Neurological function

    2 years

  • Subject Function

    2 years

  • Radiographic Measurements

    2 years

  • +1 more secondary outcomes

Study Arms (1)

Freedom Cervical Disc

EXPERIMENTAL
Device: Freedom Cervical Disc

Interventions

Freedom Cervical DiscDEVICE
Freedom Cervical Disc

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Universitatsklinikum Bonn

Bonn, 53105, Germany

Location

Stadtisches Klinikum Gorlitz

Görlitz, 02828, Germany

Location

Stadtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Klinik St. Anna

Lucerne, CH-6006, Switzerland

Location

Spine Center Rischke

Zurich, CH 8001, Switzerland

Location

MeSH Terms

Conditions

Dowling-Degos DiseaseIntervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 9, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

CH(2)DE(3)