CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease

May 22, 2014 updated by: DePuy Spine

Clinical Investigation of the SB Charite III Intervertebral Disc Spacer.

The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at one level of the lumbar spine (either L4/L5 or L5/S1).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatments for disc degeneration have historically included conservative modalities, such as rest, heat, electrotherapy, physical therapy, and analgesics to surgery. Currently, there are two main surgical techniques for treatment of disc degeneration: (1) nucleotomy or diskectomy, i.e., excision of part or all of the degenerated disc, which is typically performed for treatment of radicular syndrome in the case of disc herniation; and (2) spinal fusion, i.e., grafting bone between the vertebrae adjacent to the degenerated disc to eliminate articulation at the damaged segment, which is typically performed for treatment of degeneration together with instability and reduction of the intervertebral space. Rigid internal fixation may also be used to promote fusion.

The CHARITÉ Artificial Disc is designed to provide a new therapeutic option for treatment of degenerative disc disease as an alternative to spinal fusion to preserve function in the lumbar vertebral region. Each institution participating in the study was to treat the first 5 consecutive study participants with the CHARITE to as it involves a modification to the technique used for anterior fusion. Data will be collected on these "training" cases but will not be included in the comparison with the control (fusion) treatment.

Comparison: Outcomes for patients treated with the CHARITÉ Artificial Disc will be compared to outcomes for patients treated with anterior lumbar interbody fusion.

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 60 years of age inclusive
  • symptomatic degenerative disc disease confirmed by provocative discogram
  • single level disease L4/L5 or L5/S1
  • leg or back pain without nerve root compression
  • VAS pain score >= 40
  • Oswestry Disability Index score >= 30
  • six months prior conservative treatment
  • appropriate for anterior surgical approach

Exclusion Criteria:

  • previous lumbar or thoracic fusion
  • other spinal surgery at target level
  • symptomatic multiple level degeneration
  • non-contained or extruded nucleus pulposus
  • compression or burst at L4, L5, or S1 due to trauma
  • mid-sagittal stenosis < 8mm
  • osteoporosis, osteopenia, or other metabolic bone disease of the spine
  • spondylolisthesis > 3mm, scoliosis > 11 degrees
  • facet joint arthrosis
  • isthmic spondylolisthesis
  • positive straight leg raise for radiculopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumbar TDR
CHARITÉ Artificial Disc
Device: CHARITÉ Artificial Disc
Active Comparator: ALIF
Anterior Interbody Fusion with BAK Cage
Device: Anterior Interbody Fusion with BAK Cage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain and Function (Oswestry Disability Index)
Neurologic Function
Major Adverse Events
Subsequent Surgical Interventions

Secondary Outcome Measures

Outcome Measure
Adverse Events
Back and Leg Pain (VAS)
SF-36; Health Related Quality of Life
Disc Space Height
Fusion (control only)
Angular Range of Motion
Duration of Hospitalization
Work Status
Patient Satisfaction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Spine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 990303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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