Limits...
Hybrid Biosynthetic Autograft Extender for Use in Posterior Lumbar Interbody Fusion: Safety and Clinical Effectiveness.

Chedid MK, Tundo KM, Block JE, Muir JM - Open Orthop J (2015)

Bottom Line: The purpose of this study was to document the clinical effectiveness and safety of a novel hybrid biosynthetic scaffold material consisting of poly(D,L-lactide-co-glycolide) (PLGA, 75:25) combined by lyophilization with unmodified high molecular weight hyaluronic acid (10-12% wt:wt) as an extender for a broad range of spinal fusion procedures.Mean pain scores (+SD) for all patients improved from 6.8+2.5 at baseline to 3.6+2.9 at approximately 12 months.Only 15 of 236 levels (6.4%) were non-fused at final follow-up.

View Article: PubMed Central - PubMed

Affiliation: Henry Ford Health System - West Bloomfield Michigan, 6777 West Maple Road, West Bloomfield, MI 48322, USA.

ABSTRACT
Autologous iliac crest bone graft is the preferred option for spinal fusion, but the morbidity associated with bone harvest and the need for graft augmentation in more demanding cases necessitates combining local bone with bone substitutes. The purpose of this study was to document the clinical effectiveness and safety of a novel hybrid biosynthetic scaffold material consisting of poly(D,L-lactide-co-glycolide) (PLGA, 75:25) combined by lyophilization with unmodified high molecular weight hyaluronic acid (10-12% wt:wt) as an extender for a broad range of spinal fusion procedures. We retrospectively evaluated all patients undergoing single- and multi-level posterior lumbar interbody fusion at an academic medical center over a 3-year period. A total of 108 patients underwent 109 procedures (245 individual vertebral levels). Patient-related outcomes included pain measured on a Visual Analog Scale. Radiographic outcomes were assessed at 6 weeks, 3-6 months, and 1 year postoperatively. Radiographic fusion or progression of fusion was documented in 221 of 236 index levels (93.6%) at a mean (±SD) time to fusion of 10.2+4.1 months. Single and multi-level fusions were not associated with significantly different success rates. Mean pain scores (+SD) for all patients improved from 6.8+2.5 at baseline to 3.6+2.9 at approximately 12 months. Improvements in VAS were greatest in patients undergoing one- or two-level fusion, with patients undergoing multi-level fusion demonstrating lesser but still statistically significant improvements. Overall, stable fusion was observed in 64.8% of vertebral levels; partial fusion was demonstrated in 28.8% of vertebral levels. Only 15 of 236 levels (6.4%) were non-fused at final follow-up.

No MeSH data available.


Related in: MedlinePlus

Sagittal (A, C) and coronal (B, D) CT images at 9 months (A, B) and 16 months (C, D) post-op in a 54-year-old male who underwent 2-level posterior lumbar interbody fusion at L4-S1 (yellow arrows). The patient complained of low back pain and left buttock pain after failed previous fusion at L5-S1. Nine-month imaging demonstrates progression to fusion (A, B), with complete fusion realized by 16-month imaging at the time fusion was extended to include L2-L4 (C, D). Low back pain and radiculopathy resolved following re-operation.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4493627&req=5

Figure 1: Sagittal (A, C) and coronal (B, D) CT images at 9 months (A, B) and 16 months (C, D) post-op in a 54-year-old male who underwent 2-level posterior lumbar interbody fusion at L4-S1 (yellow arrows). The patient complained of low back pain and left buttock pain after failed previous fusion at L5-S1. Nine-month imaging demonstrates progression to fusion (A, B), with complete fusion realized by 16-month imaging at the time fusion was extended to include L2-L4 (C, D). Low back pain and radiculopathy resolved following re-operation.

Mentions: Data at final follow-up were available for 236 of 245 individual levels in 105 patients. A total of 221 of 236 vertebral levels (93.6%) fulfilled the success criteria for fusion at final follow-up by demonstrating partial or comp-lete fusion (see Table 4). Partial fusion was demonstrated at 68 of 236 fusion levels (28.8%) at final follow-up while 153 of 236 levels (64.8%) demonstrated complete fusion. Only 15 of 236 levels (6.4%) showed no evidence of fusion at final follow-up. The mean time to fusion for the entire group was 10.2 months (±4.1). An example of solid fusion is demonstrated in Fig. (1).


Hybrid Biosynthetic Autograft Extender for Use in Posterior Lumbar Interbody Fusion: Safety and Clinical Effectiveness.

Chedid MK, Tundo KM, Block JE, Muir JM - Open Orthop J (2015)

Sagittal (A, C) and coronal (B, D) CT images at 9 months (A, B) and 16 months (C, D) post-op in a 54-year-old male who underwent 2-level posterior lumbar interbody fusion at L4-S1 (yellow arrows). The patient complained of low back pain and left buttock pain after failed previous fusion at L5-S1. Nine-month imaging demonstrates progression to fusion (A, B), with complete fusion realized by 16-month imaging at the time fusion was extended to include L2-L4 (C, D). Low back pain and radiculopathy resolved following re-operation.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4493627&req=5

Figure 1: Sagittal (A, C) and coronal (B, D) CT images at 9 months (A, B) and 16 months (C, D) post-op in a 54-year-old male who underwent 2-level posterior lumbar interbody fusion at L4-S1 (yellow arrows). The patient complained of low back pain and left buttock pain after failed previous fusion at L5-S1. Nine-month imaging demonstrates progression to fusion (A, B), with complete fusion realized by 16-month imaging at the time fusion was extended to include L2-L4 (C, D). Low back pain and radiculopathy resolved following re-operation.
Mentions: Data at final follow-up were available for 236 of 245 individual levels in 105 patients. A total of 221 of 236 vertebral levels (93.6%) fulfilled the success criteria for fusion at final follow-up by demonstrating partial or comp-lete fusion (see Table 4). Partial fusion was demonstrated at 68 of 236 fusion levels (28.8%) at final follow-up while 153 of 236 levels (64.8%) demonstrated complete fusion. Only 15 of 236 levels (6.4%) showed no evidence of fusion at final follow-up. The mean time to fusion for the entire group was 10.2 months (±4.1). An example of solid fusion is demonstrated in Fig. (1).

Bottom Line: The purpose of this study was to document the clinical effectiveness and safety of a novel hybrid biosynthetic scaffold material consisting of poly(D,L-lactide-co-glycolide) (PLGA, 75:25) combined by lyophilization with unmodified high molecular weight hyaluronic acid (10-12% wt:wt) as an extender for a broad range of spinal fusion procedures.Mean pain scores (+SD) for all patients improved from 6.8+2.5 at baseline to 3.6+2.9 at approximately 12 months.Only 15 of 236 levels (6.4%) were non-fused at final follow-up.

View Article: PubMed Central - PubMed

Affiliation: Henry Ford Health System - West Bloomfield Michigan, 6777 West Maple Road, West Bloomfield, MI 48322, USA.

ABSTRACT
Autologous iliac crest bone graft is the preferred option for spinal fusion, but the morbidity associated with bone harvest and the need for graft augmentation in more demanding cases necessitates combining local bone with bone substitutes. The purpose of this study was to document the clinical effectiveness and safety of a novel hybrid biosynthetic scaffold material consisting of poly(D,L-lactide-co-glycolide) (PLGA, 75:25) combined by lyophilization with unmodified high molecular weight hyaluronic acid (10-12% wt:wt) as an extender for a broad range of spinal fusion procedures. We retrospectively evaluated all patients undergoing single- and multi-level posterior lumbar interbody fusion at an academic medical center over a 3-year period. A total of 108 patients underwent 109 procedures (245 individual vertebral levels). Patient-related outcomes included pain measured on a Visual Analog Scale. Radiographic outcomes were assessed at 6 weeks, 3-6 months, and 1 year postoperatively. Radiographic fusion or progression of fusion was documented in 221 of 236 index levels (93.6%) at a mean (±SD) time to fusion of 10.2+4.1 months. Single and multi-level fusions were not associated with significantly different success rates. Mean pain scores (+SD) for all patients improved from 6.8+2.5 at baseline to 3.6+2.9 at approximately 12 months. Improvements in VAS were greatest in patients undergoing one- or two-level fusion, with patients undergoing multi-level fusion demonstrating lesser but still statistically significant improvements. Overall, stable fusion was observed in 64.8% of vertebral levels; partial fusion was demonstrated in 28.8% of vertebral levels. Only 15 of 236 levels (6.4%) were non-fused at final follow-up.

No MeSH data available.


Related in: MedlinePlus