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

Degenerative Disc Disease Clinical Trial

Official title:

Clinical Investigation of the SB Charite III Intervertebral Disc Spacer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215306
• Other study ID #: 990303
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 22, 2014
• Start date: March 2000
• Est. completion date: March 2004

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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• CHARITÉ Artificial Disc

• Anterior Interbody Fusion with BAK Cage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Spine

References & Publications (3)

Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, Garcia R Jr, Regan JJ, Ohnmeiss DD. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with t — View Citation

Geisler FH, Blumenthal SL, Guyer RD, McAfee PC, Regan JJ, Johnson JP, Mullin B. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a mu — View Citation

McAfee PC, Cunningham B, Holsapple G, Adams K, Blumenthal S, Guyer RD, Dmietriev A, Maxwell JH, Regan JJ, Isaza J. A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and Function (Oswestry Disability Index)
Primary	Neurologic Function
Primary	Major Adverse Events
Primary	Subsequent Surgical Interventions
Secondary	Adverse Events
Secondary	Back and Leg Pain (VAS)
Secondary	SF-36; Health Related Quality of Life
Secondary	Disc Space Height
Secondary	Fusion (control only)
Secondary	Angular Range of Motion
Secondary	Duration of Hospitalization
Secondary	Work Status
Secondary	Patient Satisfaction