Blumenthal (2005) — A prospective, randomized, multicenter IDE study of lumbar total disc replacement with the CHARITÉ™ artificial disc versus lumbar fusion - Part I: Evaluation of clinical outcomes

A Prospective, Randomized, Multicenter Ide Study of Lumbar Total Disc Replacement with the Charité™ Artificial Disc versus Lumbar Fusion - Part I: Evaluation of Clinical Outcomes

·Spine·2005·585 citations·Spine

This FDA-regulated prospective RCT enrolled 304 patients at 14 US centers to compare lumbar total disc replacement (CHARITÉ artificial disc) vs. instrumented ALIF (BAK cages with iliac crest autograft) for single-level L4-S1 degenerative disc disease unresponsive to ≥6 months of conservative care, following patients for 24 months with ODI, VAS, and SF-36 outcomes.

Study Snapshot

Design

Multicenter RCT

Blinding: Open-label

Setting: 14 sites across United States

Funding: Industry (DePuy Spine)

Objective

Whether lumbar total disc replacement is clinically equivalent to anterior lumbar fusion

Outcome(s)

Clinical success: ≥25% ODI improvement, no device failure, no major complications at 24 months

Subjects

304 patients; 205 disc replacement, 99 fusion

205CHARITÉ artificial disc replacement via anterior approach
99ALIF with BAK cages + iliac crest autograft

Inclusion

Single-level DDD at L4–S1
ODI ≥30, VAS ≥40
Failed ≥6 months nonoperative care

Exclusion

Previous thoracic or lumbar fusion
Spondylolisthesis >3mm or scoliosis >11°
Osteoporosis or metabolic bone disease

Follow-up

24 months

Statistics

Fisher's exact testStudent t-testBlackwelder equivalence test

Key Findings

Non-inferiority was met: overall clinical success reached 57.1% (TDR) vs. 46.5% (fusion) across all randomized patients (P=0.0001), and 63.6% vs. 56.8% among 24-month completers — establishing disc replacement as at least equivalent to fusion
Functional recovery favored TDR early, then converged: ODI and VAS improvement was statistically greater in TDR at every time point through 12 months (P<0.05), with groups equalizing by 24 months (ODI reduction 48.5% vs. 42.4%, P=0.267) — early gains matter for return to work and activity
Patient satisfaction at 24 months was markedly higher after disc replacement: 73.7% vs. 53.1% reported satisfaction (P=0.0011), and 69.9% vs. 50.0% would choose the same surgery again (P=0.0062) — a gap that persisted despite equivalent late functional scores
Reoperation and resource utilization favored TDR:
–Revision/removal rates were 5.4% vs. 9.1% (P=0.4484)
–Hospital stay was shorter by approximately one day (3.7 vs. 4.2 days, P=0.0039)
–Overall complication rates were equivalent
Narcotic use during follow-up was significantly lower in TDR patients (72.2% vs. 85.9%, P=0.0083); donor site pain affected 18.2% of fusion patients exclusively — a complication category absent from the disc replacement group entirely

Clinical Relevance

This study forms the evidence base for offering total disc replacement to appropriate candidates with single-level L4-S1 degenerative disc disease.

The data support counseling patients that disc replacement offers at least equivalent pain relief and functional improvement compared to fusion, with potentially faster recovery and higher long-term satisfaction rates.

Supplemental

A Prospective, Randomized, Multicenter Ide Study of Lumbar Total Disc Replacement with the Charité™ Artificial Disc versus Lumbar Fusion - Part I: Evaluation of Clinical Outcomes

Blumenthal, Ohnmeiss, et al.·Spine·2005·585 citations·Spine

A Prospective, Randomized, Multicenter Ide Study of Lumbar Total Disc Replacement with the Charité™ Artificial Disc versus Lumbar Fusion - Part I: Evaluation of Clinical Outcomes

Study Snapshot

Key Findings

Clinical Relevance

Related Articles

A Prospective, Randomized, Multicenter Ide Study of Lumbar Total Disc Replacement with the Charité™ Artificial Disc versus Lumbar Fusion - Part I: Evaluation of Clinical Outcomes

Study Snapshot

Key Findings

Clinical Relevance

Related Articles

A Prospective, Randomized, Multicenter Ide Study of Lumbar Total Disc Replacement with the Charité™ Artificial Disc versus Lumbar Fusion - Part I: Evaluation of Clinical Outcomes

Study Snapshot

Key Findings

Clinical Relevance

Related Articles

A Prospective, Randomized, Multicenter Ide Study of Lumbar Total Disc Replacement with the Charité™ Artificial Disc versus Lumbar Fusion - Part I: Evaluation of Clinical Outcomes

Study Snapshot

Key Findings

Clinical Relevance

Related Articles