NCT00215293

Brief Summary

The purpose of this study is to determine the clinical success of the Cervical I/F Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft, autograft with a plate or allograft with a plate

Trial Health

100
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2000

Longer than P75 for phase_3

Status
completed

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

Study Start

First participant enrolled

August 1, 2000

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

7.2 years

First QC Date

September 13, 2005

Last Update Submit

May 22, 2014

Conditions

Cervical Intervertebral Disc Degeneration

Keywords

fusioncervicalspine

Outcome Measures

Primary Outcomes (4)

  • Fusion Status

    24 months

  • Neck Disability Index

  • Neurological Status

  • Secondary Surgical Interventions

Secondary Outcomes (7)

  • Adverse Events

  • Donor Site Pain

  • Neck Pain

  • Arm Pain

  • Disc Space Height

  • +2 more secondary outcomes

Study Arms (2)

Cervical Cage

EXPERIMENTAL

Cervical I/F Cage

Device: Cervical I/F Cage

Graft Spacer

ACTIVE COMPARATOR

Autograft or allograft with a plate, or autograft alone.

Device: Autograft or allograft with a plate, or autograft alone.

Interventions

Cervical I/F CageDEVICE
Cervical Cage
Autograft or allograft with a plate, or autograft alone.DEVICE
Graft Spacer

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent recurrent neck and/or shoulder and arm pain refractory to 6 weeks of non-surgical therapy.
  • Radiographic evidence of significant disc degeneration at one or two adjacent cervical levels (C4-7)

You may not qualify if:

  • Significant degeneration at more than two cervical levels,
  • Prior surgical treatment of the cervical spine; laminotomy or foraminotomy allowed,
  • Gross instability due to trauma,
  • Disability in the lumbar spine,
  • Infection in the disc or spine, past or present,
  • Any active infection at time of surgery,
  • Tumor in the spine,
  • Significant osteoporosis or metabolic bone disease,
  • Pregnant, lactating or wishes to become pregnant within duration of the study,
  • Refusal to accept the use of autograft tissue.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transplantation, AutologousTransplantation, Homologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

August 1, 2000

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 23, 2014

Record last verified: 2014-05