Cervical I/F Cage for Anterior Cervical Fusion

Cervical Intervertebral Disc Degeneration Clinical Trial

Official title:

A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215293
• Other study ID #: G000019
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 22, 2014
• Start date: August 2000
• Est. completion date: October 2007

Study information

• Verified date: May 2014
• Source: DePuy Spine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Intervertebral Disc Degeneration
• Intervertebral Disc Degeneration

Intervention

Device:
• Cervical I/F Cage

• Autograft or allograft with a plate, or autograft alone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Spine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion Status		24 months	No
Primary	Neck Disability Index			No
Primary	Neurological Status			Yes
Primary	Secondary Surgical Interventions			Yes
Secondary	Adverse Events			Yes
Secondary	Donor Site Pain			No
Secondary	Neck Pain			No
Secondary	Arm Pain			No
Secondary	Disc Space Height			No
Secondary	Sagittal Alignment			No
Secondary	SF-36, Health Related Quality of Life			No