Heller (2009) — Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial.

Comparison of Bryan Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion: Clinical and Radiographic Results of a Randomized, Controlled, Clinical Trial.

·Spine·2009·514 citations·Spine

Prospective, randomized, multicenter FDA IDE trial (n=463) comparing the Bryan Cervical Disc arthroplasty to single-level ACDF in patients with radiculopathy or myelopathy from single-level cervical disc disease. The study was designed as a noninferiority trial with a predefined superiority hypothesis, reporting 24-month clinical and radiographic outcomes.

Study Snapshot

Design

Multicenter RCT

Blinding: Open-label

Objective

Determine whether cervical disc arthroplasty is safer and more effective than fusion

Outcome(s)

Neck Disability Index score and overall success at 24 months

Subjects

463 patients

242Arthroplasty
221Fusion

Inclusion

Single-level cervical disc disease
Persistently symptomatic
Requiring surgical decompression

Follow-up

24 months

Key Findings

At 24 months, arthroplasty outperformed ACDF on the composite primary endpoint — 82.6% vs. 72.7% overall success (P = 0.010) — a superiority finding in a trial designed only to prove noninferiority
Disability improvement followed the same pattern: 86.0% vs. 78.9% NDI success (P = 0.035), with the arthroplasty group showing greater neck pain reduction at every follow-up interval
Arthroplasty patients returned to work a median of 13 days earlier (48 vs. 61 days, P = 0.015), without any corresponding increase in adverse events — suggesting earlier mobilization is safe when no fusion mass requires protection
Serious implant-related adverse events were low and statistically equivalent: 1.7% arthroplasty vs. 3.2% ACDF; secondary surgery rates were similarly comparable (2.5% vs. 3.6%)
Motion was preserved at 2 years in the arthroplasty group (mean ROM 8.1°), while the ACDF group achieved a 94.3% fusion rate — confirming both devices performed as intended radiographically

Clinical Relevance

When evaluating a patient with single-level cervical disc disease causing radiculopathy or myelopathy who has failed ≥6 weeks of nonoperative management, cervical disc arthroplasty is a viable alternative to ACDF — with Level I evidence showing superior composite outcomes and faster return to work at 2 years, provided contraindications (significant spondylosis, instability, kyphosis, facet arthrosis, osteoporosis) are absent.

Supplemental

Comparison of Bryan Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion: Clinical and Radiographic Results of a Randomized, Controlled, Clinical Trial.

Comparison of Bryan Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion: Clinical and Radiographic Results of a Randomized, Controlled, Clinical Trial.

Study Snapshot

Key Findings

Clinical Relevance

Related Articles

Comparison of Bryan Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion: Clinical and Radiographic Results of a Randomized, Controlled, Clinical Trial.

Study Snapshot

Key Findings

Clinical Relevance

Related Articles

Comparison of Bryan Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion: Clinical and Radiographic Results of a Randomized, Controlled, Clinical Trial.

Study Snapshot

Key Findings

Clinical Relevance

Related Articles

Comparison of Bryan Cervical Disc Arthroplasty with Anterior Cervical Decompression and Fusion: Clinical and Radiographic Results of a Randomized, Controlled, Clinical Trial.

Study Snapshot

Key Findings

Clinical Relevance

Related Articles