Cervical I/F Cage for Anterior Cervical Fusion

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2006 by DePuy Spine.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

DePuy Spine

ClinicalTrials.gov Identifier:

NCT00215293

First received: September 13, 2005

Last updated: October 3, 2006

Last verified: October 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	September 13, 2005
Last Updated Date	October 3, 2006
Start Date ^ICMJE	August 2000
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2005)	Fusion Status Neck Disability Index Neurological Status Secondary Surgical Interventions
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00215293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 14, 2005)	Adverse Events Donor Site Pain Neck Pain Arm Pain Disc Space Height Sagittal Alignment SF-36, Health Related Quality of Life
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cervical I/F Cage for Anterior Cervical Fusion
Official Title ^ICMJE	A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion
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
Detailed Description	This is a prospective randomized multi-center clinical trial to assess the safety and efficacy of the investigational device, Cervical I/F Cage for fusion in one or two adjacent levels of the cervical spine. Patients will be randomly assigned in a ration of 1:1 between the investigational and control groups. Comparison: The device will be compared to a control group consisting of the 3 accepted standard of care treatments (autograft, autograft with an anterior plate, or allograft with an anterior plate). For two level fusions, the control group will be limited to autograft with a plate or allograft with a plate. Based on the current literature, it is believed that there is no difference between the three treatments in terms of clinical success, fusion success, or safety issues. However, amongst the investigators there are preferred treatments. Each investigator will choose one or more of the control treatments at study initiation. Patients will then be randomized in a 1:1 Cage:control randomization schema. Approximately 240 subjects will be enrolled at 20 sites. Eligible patients will have symptomatic degeneration of one or two adjacent cervical discs, have failed six weeks of non-surgical treatment, have sufficiently severe enough symptoms to warrant surgery, and have had no prior fusion surgery on the cervical spine.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Degenerative Disc Disease in One or Two Adjacent Levels in the Cervical Spine
Intervention ^ICMJE	Device: Cervical I/F Cage Procedure: Standard Cervical Fusion
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	240
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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) Exclusion Criteria: 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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00215293
Other Study ID Numbers ^ICMJE	G000019
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	DePuy Spine
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	DePuy Spine
Verification Date	October 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top