title: Gene therapy and cement injection for restabilization of loosened hip prostheses.
abstract: Loosening of orthopedic hip prostheses is an increasing health problem. In elderly patients with comorbidity,revision surgery may lead to high mortality rates. A less invasive surgical technique is therefore required to reduce these patient risks. To this end a percutaneous gene therapy approach was designed to destroy the periprosthetic loosening membrane, and enable refixing of the hip prosthesis with percutaneous bone cement injections under radiological guidance. In this phase 1/2 dose-escalating gene therapy clinical trial, 12 patients were treated. Toxicity and hip function variables were monitored up to 6 months posttreatment. All patients completed the study and no dose-limiting toxicity was observed. Improvement in walking distance, independence,and pain was demonstrated particularly in patients receiving 3 x 10(10) and 1 x 10(11) viral particles. Taken together, these data show that this gene therapy approach targeted at the interface membrane around a loosened hip prosthesis is a feasible treatment option for elderly patients for whom surgical intervention is not appropriate.
authors: Department of Orthopedics, Leiden University Medical Center, 2300 RC, Leiden, The Netherlands.
authors: Jolanda J
authors: JJ
authors: de Poorter
authors: Rob C
authors: RC
authors: Hoeben
authors: Simone
authors: S
authors: Hogendoorn
authors: Vivien
authors: V
authors: Mautner
authors: John
authors: J
authors: Ellis
authors: Wim R
authors: WR
authors: Obermann
authors: Tom W J
authors: TW
authors: Huizinga
authors: Rob G H H
authors: RG
authors: Nelissen
mesh_terms: D000368:Aged; D001843:Bone Cements; D002484:Cementation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D015316:Genetic Therapy / Q000379:methods*; D006620:Hip Fractures / Q000000981:diagnostic imaging / Q000628:therapy*; D006622:Hip Prosthesis; D006801:Humans; D007267:Injections; D008297:Male; D011474:Prosthesis Design; D011859:Radiography
chemical_list: D001843:Bone Cements