Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia.

INTRODUCTION: Hip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse. METHODS AND ANALYSIS: The iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60. ETHICS AND DISSEMINATION: iHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals. TRIAL REGISTRATION NUMBER: DRKS00013644; Pre-results.

Functional long-term results after the harvest of vascularised iliac bone grafts bicortically with the anterior superior iliac spine included.

The aim of this study was to evaluate the postoperative morbidity at the donor site and the long-term outcome after the harvest of bicortical iliac bone grafts, including the iliac crest and the anterior superior iliac spine (ASIS), by using a confirmed score. We retrospectively examined 54 consecutive patients who had had vascularised iliac bone grafts harvested to reconstruct different parts of the mandible. We used the Harris Hip Score to evaluate objectively the long-term postoperative morbidity at the donor site. Of 54 patients, 20 were female (37%) and 34 male (63%), with a mean age of 49 years (range 12-81). The causes of the bony defects were malignancy (n=37, 69%), benign tumours (n=7, 13%), osteomyelitis (n=9, 17%), and atrophy of the alveolar ridge (n=1, 2%). All transplants healed adequately. A total of 38/52 patients (73%) had a score of more than 80 points, which defines clinical success. Vascularised iliac bone grafts offer excellent bony dimensions with optimal shape to be used for reconstruction of different parts of the mandible. They can be harvested bicortically, including the iliac crest and the ASIS, with acceptable morbidity at the donor site. The Harris Hip Score is an appropriate tool for the evaluation of long-term impairment at the donor site after the harvest of vascularised iliac bone grafts, and it could be used to compare the results of different studies.