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

NCT ID: NCT00215306

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31
• Study Completion Date: 2004-03-31

Brief 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).

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.

Conditions

Degenerative Disc Disease

Study Design

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

Study Groups

Lumbar TDR

CHARITÉ Artificial Disc

Group Type: EXPERIMENTAL

CHARITÉ Artificial Disc

Intervention Type: DEVICE

ALIF

Anterior Interbody Fusion with BAK Cage

Group Type: ACTIVE_COMPARATOR

Anterior Interbody Fusion with BAK Cage

Intervention Type: DEVICE

Interventions

CHARITÉ Artificial Disc

Intervention Type: DEVICE

Anterior Interbody Fusion with BAK Cage

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Spine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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 the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1565-75; discussion E387-91. doi: 10.1097/01.brs.0000170587.32676.0e.

Reference Type: RESULT

PMID: 16025024 (View on PubMed)

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 with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1576-83; discussion E388-90. doi: 10.1097/01.brs.0000170561.25636.1c.

Reference Type: RESULT

PMID: 16025025 (View on PubMed)

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 multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. J Neurosurg Spine. 2004 Sep;1(2):143-54. doi: 10.3171/spi.2004.1.2.0143.

Reference Type: RESULT

PMID: 15346999 (View on PubMed)

Other Identifiers

990303

Identifier Type: -

Identifier Source: org_study_id