title: Clinical experience with a new fast-resorbing polymer for bone stabilization in craniofacial surgery.
abstract: Polylactic acid (PLA) and polyglycolic acid have been successfully used as suture material during the past 30 years and have been successfully used in various orthopedic and craniofacial applications, with increasing frequency during the past 15 years. To eliminate some of the problems seen with the longer-lasting Macropore PLA product and other longer-lasting resorbable systems, a new fast-resorbing polymer (FRP) was manufactured by Macropore-Medtronic Neurologic Technologies, Inc. from commercially available 85:15 poly(D,L-lactide-co-glycolide) raw material using traditional melt-processing techniques. The delivery system is easily used and uses essentially the same instrumentation. One hundred and sixty eight patients who had implantation of the FRP were studied. Detailed clinical evaluation was completed after surgery and at each postoperative visit. Overall, there was a 2.1% implant-related complication rate, which compared favorably to the 8.5% implant-related complication rate associated with the longer-lasting PLA product. All patients who received FRP implants have had maintenance of stable bony fixation, followed by bony healing and satisfactory or excellent cosmetic results. The results from the FRP study indicate that the FRP material and implants are safe and effective in craniomaxillofacial applications.
authors.affiliation: Children's Hospital of San Diego, San Diego, CA, USA. scohen@sdfaces.com
authors.forename: Steven R
authors.initials: SR
authors.lastname: Cohen
authors.forename: Paul A
authors.initials: PA
authors.lastname: Mittermiller
authors.forename: Ralph E
authors.initials: RE
authors.lastname: Holmes
authors.forename: Kevin W
authors.initials: KW
authors.lastname: Broder
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects; D000293:Adolescent; D001672:Biocompatible Materials / Q000737:chemistry*; D003398:Craniosynostoses / Q000601:surgery; D004677:Encephalocele / Q000601:surgery; D004954:Esthetics; D005147:Facial Bones / Q000601:surgery*; D005500:Follow-Up Studies; D005546:Forehead / Q000601:surgery; D006801:Humans; D006972:Hypertelorism / Q000601:surgery; D016268:Internal Fixators / Q000009:adverse effects; D019344:Lactic Acid / Q000737:chemistry*; D009984:Orthopedic Fixation Devices / Q000009:adverse effects; D011100:Polyglycolic Acid / Q000737:chemistry*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011108:Polymers / Q000737:chemistry*; D011183:Postoperative Complications; D011446:Prospective Studies; D012886:Skull / Q000601:surgery*; D012888:Skull Neoplasms / Q000601:surgery; D014945:Wound Healing / Q000502:physiology
chemical_list: D001672:Biocompatible Materials; D011108:Polymers; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid