Abstract
BackgroundPercutaneous kyphoplasty (PKP) is the first-line treatment for osteoporotic vertebral compression fractures (OVCFs) that can immediately relieve pain and allow the quick recovery of lost mobility. However, some studies reported that after PKP, the incidence of vertebral refracture, particularly adjacent vertebral fracture (AVF), was high. Our previous meta-analysis suggested that the risks for vertebral refracture and AVF did not increase after percutaneous vertebral augmentation in OVCF patients. Despite the negative results of our meta-analysis, there is still significant evidence regarding the relationship between kyphoplasty and AVF, so a new prospective cohort study is warranted. In addition, in our previous retrospective study, we found that advanced age, female sex and low oestradiol (E2) concentrations might be related to the occurrence of postoperative vertebral refracture after PKP. To sufficiently evaluate the probable factors involved in the occurrence of postoperative vertebral refracture, we designed this prospective study.MethodsThis is a prospective cohort study of patients admitted for PKP to treat painful OVCFs. The baseline data, including demographic information, lifestyle, bone metabolic status, sex hormone and sex hormone-binding globulin (SHBG) levels, and clinical characteristics will be collected at the time of enrolment. Surgical features of PKP will be recorded on the operation day. Lifestyle, bone metabolic status, sex hormone levels, and SHBG levels will be assessed during the follow-up period at 1 m, 3 m, 12 m, and 24 m postoperatively. Patients suffering from acutely aggravated back pain will be referred to an orthopaedist, and refractured vertebrae will be confirmed by magnetic resonance imaging and computed tomography. The primary outcome will be the incidence of vertebral refracture. Multivariate analyses will be carried out to evaluate the variables that are independently correlated with vertebral refracture.DiscussionTo evaluate the risk of postoperative refracture preoperatively and to identify the surgical points related to postoperative refracture, this study will explore the risk factors related to vertebral refracture after PKP. The results may provide new information about defining OVCF patients suitable for PKP treatment.Trial registrationChiCTR-ROC-17011562. Registered on July 4th, 2017.
Highlights
Percutaneous kyphoplasty (PKP) is the first-line treatment for osteoporotic vertebral compression fractures (OVCFs) that can immediately relieve pain and allow the quick recovery of lost mobility
In 2011, an randomized controlled trial (RCT) performed in Belgium that compared 149 cases treated with kyphoplasty and 151 cases treated with conservative therapy found that kyphoplasty rapidly reduced pain and improved function, disability, and quality of life, without increasing the risk of additional vertebral fractures [4]
Those who develop aggravated back pain will be reviewed by an orthopaedist, and the information regarding lifestyle, bone metabolic status, sex hormone levels, sex hormone-binding globulin (SHBG) levels, and imaging examinations will be collected if refracture or Anthropometric data The baseline data, including gender, age, weight, height, and Body mass index (BMI) will be collected following participant recruitment (Table 1)
Summary
Study design The present study is a prospective cohort study. Participant recruitment for the study will begin in Apr 2018 and continue until Mar 2019. Patients with OVCF who are admitted to the First Affiliated Hospital of Zhejiang Chinese Medicine University will be assessed by an orthopaedist to ensure that they are eligible for the study and will sign an informed consent form and be enrolled in this study. Data collection when a patient is enrolled in this study, the baseline data will be collected, including the demographic information, lifestyle, bone metabolic status, sex hormone levels, and clinical characteristics. Complications will be defined by the Post-Operative Morbidity Survey and recorded [34] Those who develop aggravated back pain will be reviewed by an orthopaedist, and the information regarding lifestyle, bone metabolic status, sex hormone levels, SHBG levels, and imaging examinations will be collected if refracture or Anthropometric data The baseline data, including gender, age, weight, height, and BMI will be collected following participant recruitment (Table 1). We will deliver a deidentified dataset to the Clinical Trial Management Public Platform for release before December 2021
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