First interdisciplinary medical device study started by the MHH Clinic for Trauma Surgery together with the new ZKS in the CRC
The Department of Trauma Surgery and the medical team from the Early Clinical Trial Unit of the Center for Clinical Studies (ZKS) jointly initiated the industry-sponsored RESTORE study. This randomized controlled trial is evaluating a local osteoenhancement procedure (LOEP) for its ability to prevent secondary hip fractures in women with osteoporosis undergoing treatment for index hip fractures. The patient population examined in this study consists of women with reduced bone density and a high risk of a second hip fracture on the non-injured side. For patients who volunteer for this study, hip fracture treatment will be expanded to include treating the uninjured hip with a procedure to strengthen the bone and prevent fracture. In the treated group, the second hip is stabilized by injecting an artificial bone implant material, which is a mixture of calcium phosphates and calcium sulfate. In the control group, the patients receive no such treatment. The surgical part of the study is carried out in the interventional-operative area of trauma surgery on the MHH campus, the functional study follow-up part in the outpatient area of the CRC. An important study milestone in this international multicenter study has now been achieved with the inclusion of the first German patient at the MHH.