Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Aug 1;43(15):E860-E868.
doi: 10.1097/BRS.0000000000002678.

A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders

Marc Coughlan  1 , Mark Davies  2 , Adriaan K Mostert  3 , Dharmin Nanda  4 , Paul C Willems  5 , Geoffrey Rosenberg  6 , Richard Ferch  7
Affiliations
Randomized Controlled Trial

A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders

Marc Coughlan et al. Spine (Phila Pa 1976). .

Abstract

Study design: A prospective, Phase IV, multicenter, randomized study.

Objective: The aim of this study was to compare vertebral fusion success rates following posterolateral fusion [(PLF)/posterolateral intertransverse fusion (PITF)] surgery. The surgical procedure combined posterior lumbar interbody fusion (PLIF) and PLF with internal fixation over one or two levels using silicated calcium phosphate (SiCaP) or bone morphogenetic protein (BMP)-2 as graft material in patients with a degenerative disorder of the lumbar spine.

Summary of background data: Few controlled trials have evaluated the bone graft materials available to surgeons treating patients with spinal disorders, including degenerative disc disease, spondylolisthesis, and disc herniation.

Methods: Following randomization, the surgical procedure consisting of PLIF and PLF with internal fixation over one or two levels was performed using SiCaP or BMP-2. No other osteoconductive/osteoinductive graft materials were permitted. Spinal fusion was assessed radiographically at ≤24 months. Clinical outcomes (pain on visual analog scale, Oswestry Disability Index, SF-36) and adverse events (AEs) were monitored.

Results: One hundred three patients were enrolled. At 12 months, fusion was achieved in 25 of 35 (71.4%) of the SiCaP and 20 of 27 (74.1%) of the BMP-2 group, respectively (P = 1.000). At 24 months, the fusion rate was 78.6% and 84.8% for SiCaP and BMP-2, respectively (P = 0.5613). Clinical outcomes improved similarly in both groups over time. AEs were consistent with this surgical population.

Conclusion: SiCaP was safe and well tolerated in patients with degenerative spinal disorders requiring PLF and provided fusion rates similar to BMP-2.

Level of evidence: 2.

PubMed Disclaimer

References

    1. Majid K, Fischgrund JS. Degenerative lumbar spondylolisthesis: trends in management. J Am Acad Orthop Surg 2008; 16:208–215.
    1. Ekman P, Möller H, Tullberg T, et al. Posterior lumbar interbody fusion versus posterolateral fusion in adult isthmic spondylolisthesis. Spine (Phila Pa 1976) 2007; 32:2178–2183.
    1. Miura Y, Imagama S, Yoda M, et al. Is local bone viable as a source of bone graft in posterior lumbar interbody fusion? Spine (Phila Pa 1976) 2003; 28:2386–2389.
    1. Smith JA, Deviren V, Berven S, et al. Clinical outcome of trans-sacral interbody fusion after partial reduction for high-grade l5-s1 spondylolisthesis. Spine (Phila Pa 1976) 2001; 26:2227–2234.
    1. Kanayama M, Hashimoto T, Shigenobu K, et al. A prospective randomized study of posterolateral lumbar fusion using osteogenic protein-1 (OP-1) versus local autograft with ceramic bone substitute: emphasis of surgical exploration and histologic assessment. Spine (Phila Pa 1976) 2006; 31:1067–1074.

Publication types