Collapsed femoral head measured by X-ray and CT before hip replacement:study protocol for a single-center, open-label and diagnostic trial
10.3969/j.issn.2095-4344.2017.07.018
- VernacularTitle:髋关节置换前CT和X射线检查预测坏死股骨头的塌陷:单中心、开放性、诊断性试验
- Author:
Di QIN
;
Yongwei SHANG
;
Huijie LI
;
Yongtai HAN
- From:
Chinese Journal of Tissue Engineering Research
2017;21(7):1080-1085
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND: To determine the non-or collapsed osteonecrosis of the femoral head (ONFH) and degree of collapse, can help surgeons design reasonable treatment strategy for patients with ONFH. In China, articular cartilage collapse less than or greater than 2 mm, is a basis for choosing palliative surgery or hip replacement. However, the measurement of collapsed ONFH before replacement has not yet been confirmed. OBJECTIVE: To predict the collapse of femoral head before replacement by CT and X-ray examinations, and to compare with the intraoperative excised femoral head specimens.METHODS: This was a single-center, open-label and diagnostic trial, which was finished at the Third Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China. Eighty-six patients with unilateral ONFH undergoing total hip replacement were recruited, and allocated into three groups, such as X-ray, CT and specimen groups. The X-ray group underwent X-ray examination at anteroposterior pelvic (bilateral hips) at 1 week before surgery, the CT group received CT scan at bilateral hips at 1 week before surgery, and the specimen group was subjected to the removal of affected femoral head, and then directly measured using ruler and vernier caliper. Primary outcome was the sensitivity of thesethree methods for measuring collapsed femoral head. Secondary outcomes were the specificity, positive predictive value,negative predictive value, positive likelihood ratio, and negative likelihood ratio of these three methods for the diagnosisof collapsed femoral head and the diagnostic accuracy; the diagnostic consistence of CT and X-ray examinations; the height of the lateral, middle and external femoral head measured by three methods. The study was approved by the Ethics Committee of the Third Hospital of Hebei Medical University, China, and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants prior to the trial. DISCUSSION: In this study, the height of femoral head was measured and analyzed in all-dimensional and multi-anglemanner based on intraoperative removed specimens, so as to make an accurate prediction for collapsed femoral head, thus providing imaging reference for surgeons prior to choosing an appropriate operative scheme
