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.
Original language | English |
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Pages (from-to) | 83-95 |
Number of pages | 13 |
Journal | Human Gene Therapy |
Volume | 19 |
Issue number | 1 |
DOIs | |
Publication status | Published - 1 Jan 2008 |