There is a long history of glycerol-carrier demineralized bone matrices (DBM), such as Grafton® (Osteotech, Inc.) and Optium DBM® (LifeNet Health) used in orthopedic procedures. Here, human clinical evidence related to this class of implants is reported.
- Use of Demineralized Bone Matrices (DBMs) and Glycerol-Carrier
- Two-Year Fusion Rate Equivalency Between Grafton DBM Gel and Autograft in Posterolateral Spine Fusion. Spin 2004; 29:660-629. DOI. Cammisa FP, Jr., Lowery G, Gartin SR, et al.
- A total of 120 patients underwent posterolateral spine fusion with pedicle screw fixation and bone grafting. "Iliac crest autograft was implanted on one side of the spine and a [glycerol- carrier DBM]/autograft composite was implanted on the contralateral side."
- In this study, "nearly 70% of patients (81 of 120) provided complete 24-month radiographic studies. The bone graft mass was fused in 42 cases (52%) on the [glycerol-carrier DBM] side and in 44 cases (54%) on the autograft side."
- In conclusion, the authors state "[glycerol-carrier DBM] can extend a smaller quantity of autograft than is normally required to achieve a solid spinal arthrodesis."
Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Spine {Phila Pa 1976); 37(12):1083-91. DOI. Kang J, An H, Hilibrand A, Yoon ST, Kavanagh E, Boden S.- A randomized, multi-center study that investigated glycerol-carrier DBM in 28 patients and iliac crest bone graft (ICBG) in 13 patients for a single-level instrumented posterior lumbar fusion.
- After a two-year follow-up, the authors found similar fusion rates between the two groups.
- The authors concluded "the [glycerol-carrier DBM] group showed slightly better improvement in ODI [Oswestry Disability Index]... consistently higher physical function scores at 24 months...[and] there was a statistically significant greater mean intraoperative blood loss in the ICBG group."
The efficacy of the synthetic interbody cage and Grafton for anterior cervical fusion. Spine {Phila Pa 1976). 2009; 34(17):E591-5. DOI. Park HW, Lee JK, Moon SJ, Seo SK, Lee JH, Kim SH.- A total of 31 patients "with ACDF [anterior cervical discectomy and fusion] using the PEEK [polyetheretherketone] cage and DBM [Glycerol-carrier DBM]... at 42 levels," including 1, 2, and 3 levels, were reviewed.
- After a 12 month follow-up, the authors noted "using the Solis cage packed with [glycerol-carrier DBM] demonstrated good clinical and radiologic outcomes... [and] is a safe and effective alternative to the gold standard of autologous iliac bone grafts."
Augmenting local bone with Grafton demineralized bone matrix for posterolateral lumbar spine fusion: avoiding second site autologous bone harvest. Orthopedics 2000; 23:1059-64; discussion 64-5. Sassard WR, Eidman DK, Gray PM, et al.- This study evaluated mineralization and integrity of the bone graft mass among patients who underwent posterolateral fusion. Grafting consisted of a composite of [glycerol-carrier DBM] and "local" autologous bone (n=56) or iliac crest autograft alone (n=52).
- Mineralization was rated radiographically at baseline and at 3, 6, 12, and 24 months. Integrity was judged as fused or not fused.
- Results showed that mineralization ratings did not differ significantly between groups at any postoperative interval (P values of .25-1.00).
- "The percentage of patients fused was similar in both groups (60% and 56% for glycerol- carrier DBM and controls, respectively; P=.83)."
Instrumented posterolateral lumbar fusion using coralline hydroxyapatite with or without demineralized bone matrix, as an adjunct to autologous bone. Spine 1. 2001; 1(2):131-7. Thalgott JS, Giuffre JM, Fritts K, Timlin M, Klezl Z.- This study reported on treating "difficult to fuse patients, such as smokers [and] elderly patients with poor bone quality" who required posterolateral fusion.
- As an alternative to autogenous fusion, the authors used coralline hydroxapatite in 40 patients along with glycerol-carrier DBM "as a bone graft extender" in 28 of these patients (70%).
- The authors found an overall fusion rate of 89.3% in the patients that received [glycerol-carrier DBM]. The high fusion rate is especially significant when the challenging patient population is taken into account.
Fusion Rates After Thoracoscopic Release and Bone Graft Substitutes in Idiopathic Scoliosis. Spine. 33(10):p 1079-1083, May 1, 2008. I DOI. Weinzapfel B, Son-Hing JP, Armstrong DG, et al.- Investigators compared "fusion rates between allograft bone and [glycerol- carrier DBM] following VATS using standard standing lateral spine radiographs" in 68 patients with one or more year follow up. There were 40 patients with morselized graft and 28 with [glycerol-carrier DBM].
- "lnterbody fusion was assessed on standing lateral radiographs using the Newton et al. 4-level grading scale."
- They found "60 of 73 disc spaces (82%) in the Allograft group and 100 of 109 disc spaces (92%) in the [glycerol- carrier DBM] group were rated as radiographically fused" and concluded that "Demineralized bone matrix ([glycerol-carrier DBM]) seem to be an effective bone graft substitute in thoracoscopic surgery for idiopathic scoliosis."
The use of fibre-based demineralised bone matrix in majoracetabular reconstruction: surgical technique and reconstruction results. Int Orthop. 2011; 35:283- 288. Hamadouche M, Karoubi M, Dumaine V, Courpied J.- The authors described their technique and preliminary results for "major acetabular reconstruction using the Kerboull acetabular reinforcement device with allograft bone and [glycerol- carrier] DBM."
- The authors' describe the glycerol carrier DBM as "easy to handle and place in [the] acetabular cavity."
- In conclusion, the authors state "that fibre-based [sic] DBM could enhance allograft bone incorporation and remodeling in major acetabular reconstruction."
Pieske 0, Wittmann A, Zaspel J, et al. Autologous bone graft versus demineralized bone matrix in internal fixation of long bones. J Trauma Manag Outcomes, 2009; 3:11. Pieske 0, Wittmann A, Zaspel J, et al.- Data from 20 patients with ununited diaphyseal fractures of long bones were treated by ORIF [open reduction and internal fixation]. This was combined witheither ICABG [iliac-crest- autologous-bone-grafting] (n = 10) or DBM-augmentation [demineralized-bone-matrix] (n = 10).
- After a multi-year follow up (ICABG mean 56.6 months; DBM mean 41.2 months), the authors concluded "that the application of [glycerol-carrier] DBM compared to ICABG led to an advanced outcome in the treatment of non-unions and simultaneously to a decreased quantity of adverse effects."
- Furthermore, "patients treated with [glycerol-carrier] DBM were more satisfied with the surgical procedure (p = 0.031)."
Use of demineralized bone matrix in ankle/hindfoot fusion. Foot Ankle Int. 2003; 24(7):557-60. Thordarson DB, Kuehn S.- The authors investigated "sixty-three patients who underwent complex ankle or hindfoot fusion" and were divided into two groups: a glycerol-carrier demineralized bone void filler vs. a demineralized bone bone void filler, OrthoBlast®, in a reverse phase medium to stimulate fusion.
- The authors found similar fusion rates in both groups "compared to historical controls [10%]" and it should be noted these comparable rates of fusion were reached without the donor site morbidity and pain of autografts.
"Determination of Minimum Clinically Important Difference (MCID) in Pain, Disability, and Quality of Life After Revision Fusion for Symptomatic Pseudoarthrosis." Spine J. 2012 Dec; 12(12): 1122-8. Parker S, Adogwa 0, Mendenhall S, Shau D, Anderson W, Cheng J, Devin C, McGirt M.- Investigators reviewed 47 patients who underwent single-stage revision posterior pedicle screw fusion for pseudoarthrosis-associated back pain. Demineralized bone matrix (Optium®DBM Gel and Putty) and cancellous bone chips were used in all cases along with interbody grafts (96%) and bone morphogenic protein (8.5%).
- At the 2-year follow-up, all patients showed significant improvement across all patient-reported outcomes (PROs): back pain (BP-VAS), Oswestry Disability Index (ODI), physical quality of life (SF-12 PCS), and general quality of life (EQ-5D).
- In conclusion, surgery with Optium DBM led to improvements in pain, function, and quality of life two years later. However, the minimum clinically important difference (MCID) varies a lot depending on how it was measured, making it difficult to define a reliable threshold for meaningful change.
"Clinical Outcomes Following Sublaminar Decompression and Instrumented Fusion for Lumbar Degenerative Spinal Pathology." J Clin Neurosci. 2016 Aug; 30: 98-104. Peddada K, Elder B, Ishida W, Lo S, Goodwin C, Boah A, Witham T.- A retrospective study assessed a sublaminar decompression technique in 71 patients with a median age of 60 years.
- Optium DBM was one of the bone grafts used in the posterolateral arthrodesis. Imaging data for 42 patients were available for fusion assessment, and out of these, 37 patients (88%) achieved successful fusion, with a median time to fusion of 11 months (ranging from 3-17 months).
Occipital-cervical approach and stabilization. Spinal Tumor Surgery: A Case-Based Approach, 121-128. Karim Ahmed, A., Suk, I., Bydon, A., & Theodore, N. (2019).- Optium DBM Putty was used in two cases occipito-cervical (OC) fusion cases, and results showed that Optium DBM helped support bony fusion and offered effective stabilization for patients with craniovertebral instability.
DBMs using Glycerol as a carrier have e}{tensive, published clinical history and have proven effective in bone void filling applications.
*The clinical studies reported here used Grafton®DBM