Cervical I/F Cage for Anterior Cervical Fusion

NCT ID: NCT00215293

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2007-10-31

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.

Conditions

Cervical Intervertebral Disc Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cervical Cage

Cervical I/F Cage

Group Type: EXPERIMENTAL

Cervical I/F Cage

Intervention Type: DEVICE

Graft Spacer

Autograft or allograft with a plate, or autograft alone.

Group Type: ACTIVE_COMPARATOR

Autograft or allograft with a plate, or autograft alone.

Intervention Type: DEVICE

Interventions

Cervical I/F Cage

Intervention Type: DEVICE

Autograft or allograft with a plate, or autograft alone.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Spine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

G000019

Identifier Type: -

Identifier Source: org_study_id