gms | German Medical Science

Deutscher Kongress für Orthopädie und Unfallchirurgie
73. Jahrestagung der Deutschen Gesellschaft für Unfallchirurgie
95. Tagung der Deutschen Gesellschaft für Orthopädie und Orthopädische Chirurgie
50. Tagung des Berufsverbandes der Fachärzte für Orthopädie und Unfallchirurgie

21. - 24.10.2009, Berlin

Analysis of a new hemostatic and analgetic bioresorbable putty for bone surgery

Meeting Abstract

  • A. Mehrkens - Universitätsspital Basel, Orthopädische Klinik, Basel, Switzerland
  • A. M. Müller - Universitätsspital Basel, Orthopädische Klinik, Basel, Switzerland
  • L. Walz - Universitätsspital Basel, Clinical Trial Unit, Basel, Switzerland
  • S. Müller - Universitätsspital Basel, Clinical Trial Unit, Basel, Switzerland
  • V. Valderrabano - Universitätsspital Basel, Orthopädische Klinik, Basel, Switzerland

Deutscher Kongress für Orthopädie und Unfallchirurgie. 73. Jahrestagung der Deutschen Gesellschaft für Unfallchirurgie, 95. Tagung der Deutschen Gesellschaft für Orthopädie und Orthopädische Chirurgie, 50. Tagung des Berufsverbandes der Fachärzte für Orthopädie. Berlin, 21.-24.10.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. DocPO17-1655

DOI: 10.3205/09dkou686, URN: urn:nbn:de:0183-09dkou6860

Published: October 15, 2009

© 2009 Mehrkens et al.
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Outline

Text

Problem: Autografts (iliac crest bone grafts) are widely used in foot and ankle fusion procedures due to their excellent osteogenic, osteoinductive, and osteoconductive properties. However, use of autografts is associated with a donor site morbidity of up to 30%, particularly considerable postoperative pain. Standard pain treatment frequently includes use of opioid analgesics, which may cause respiratory depression, nausea, vomiting or decreased gastrointestinal motility, and thus may temporarily worsen the patient's condition and result in unfavorable outcomes, extended hospital stays, and increased costs. Xybrex™ Absorbable Hemostatic Bone Putty is a soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from the cut surface of bone. The formulation contains 16% (by weight) lidocaine which is mainly released over a 3–4 days period.

Methods: A pilot study with 14 subjects was conducted to provide initial evidence of the safety and efficacy of Xybrex for hemostasis and the treatment of postoperative pelvis pain following iliac crest bone graft (ICBG) harvest. Subjects (7 each) were assigned to be treated with either Xybrex or similar bone putty (Orthostat) that did not contain lidocaine.

Subjects were provided with patient controlled analgesia (PCA) for management of their postoperative pelvis pain for the first 3 days after surgery. Regional nerve blocks were administered for the control of the foot pain. Efficacy (pain evaluation) was monitored every 4 hours post surgery using a 100 mm Visual Analog Scale for the first 72 hours after surgery. Serial blood draws were performed at baseline and at 2, 4, 8, 12, 24, 48, and 72 hours.

Results and conclusion: The mean size of bone block taken from the iliac crest from the Xybrex subjects was 3.7±2.2 grams vs. 3.4±2.4 grams for the Orthostat subjects (p=NS). The mean amount of Xybrex applied to the resulting bone defect in the Xybrex subjects was 4.3±1.2 grams vs. 4.3±0.8 grams for the Orthostat subjects (p=NS). Subjects treated with Xybrex showed a significantly improved area under the curve of the VAS score (AUCvas) pain intensity as compared to Orthostat from 1 to 12 hours (mean AUCvas 175 vs. 250; p < 0.05). From 1 to 24 hours the differences between Xybrex and Orthostat supported the continued positive trend towards lower AUC scores for subjects treated with Xybrex but were not statistically significant. The serum levels of lidocaine reached a peak at 4-8h after application staying at all times well below the level of cardiotoxicity (6µg/ml). There were no unanticipated serious adverse effects experienced by subjects in the study. There was one seroma in the graft site that required manual expression of the serous fluid to resolve due to overload of Xybrex amount to the site. Xybrex appears to offer significant analgesic effect in the immediate post-operative period. A larger randomized study is being planned in order to verify the results from this pilot study.