Cervical I/F Cage for Anterior Cervical Fusion

Phase 3

Completed

• Conditions: Cervical Intervertebral Disc Degeneration
• Interventions: Device: Cervical I/F Cage; Device: Autograft or allograft with a plate, or autograft alone.

• Registration Number: NCT00215293
• Lead Sponsor: DePuy Spine

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 Timeline

• Study Start: 2000-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-22
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical Cage	Cervical I/F Cage	Cervical I/F Cage
Graft Spacer	Autograft or allograft with a plate, or autograft alone.	Autograft or allograft with a plate, or autograft alone.

Primary Outcome Measures

Name	Time	Method
Neurological Status
Secondary Surgical Interventions
Fusion Status	24 months
Neck Disability Index

Secondary Outcome Measures

Name	Time	Method
Adverse Events
Donor Site Pain
Neck Pain
Arm Pain
Disc Space Height
Sagittal Alignment
SF-36, Health Related Quality of Life