Local administration of mononuclear cell, platelet-rich plasma and zoledronic acid for the prevention and treatment of early femoral head osteonecrosis and collapse: study protocol for a prospective, randomized, parallel, controlled clinical trial

doi:10.3969/j.issn.2095-4344.2017.33.022

Abstract

Abstract:

BACKGROUND: There are various treatment methods for osteonecrosis of the femoral head (ONFH) and collapse, but conservative treatment is invalid. Once femoral head collapse occurs, the development is irreversible. Our previous research has shown that local administration of zoledronic acid can prevent necrotic femoral head collapse. Moreover, bone marrow mononuclear cells obtain satisfactory short-term efficacy in the treatment of ONFH.
OBJECTIVE: To investigate the curative efficacy of local administration of mononuclear cell, platelet-rich plasma and zoledronic acid for the prevention and treatment of early ONFH and collapse.
METHODS: This prospective, single-center, randomized, parallel, controlled clinical trial was conducted at the Chinese PLA General Hospital, Beijing, China. One hundred patients with ONFH (stages I-II by Ficat and Arlet classification) were enrolled and randomly assigned into either the treatment group or control group (n=50 per group). Patients were given an injection of mononuclear cell, platelet-rich plasma and zoledronic acid into the necrotic femoral head, or drilling decompression at the necrotic area. Patients in both groups were then followed up for 4, 8, 12, and 18 months. The primary outcome measures were the blood supply, osteogenesis and appearance of the necrotic femoral head observed on hip perfusion by dynamic MRI, CT restruction of the hip joint and radiography of the hip joint, as well as Harris hip scores and numerical rating scale scores. Secondary outcome measures included SF-36 Health Survey and Activities of Daily Living scores.
DISCUSSION: The outcomes of this trial have provided quantitative data for analyzing the effectiveness of local administration of mononuclear cell, platelet-rich plasma and zoledronic acid on ONFH and collapse. Written approval for this protocol was obtained from the Ethics Committee of the Chinese PLA General Hospital in China (approval No. S2015-082-01). Participants and their families are informed of the study protocol and procedures, and signed an informed consent. The study was in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Trial began in January 2015 and will be completed in December 2017. Trial results will be published in scientific reports, or in peer-reviewed journals. This trial was registered with the ClinicalTrials.gov identifier: NCT02721940. Patient recruitment is ongoing.

中国组织工程研究杂志出版内容重点：干细胞；骨髓干细胞；造血干细胞；脂肪干细胞；肿瘤干细胞；胚胎干细胞；脐带脐血干细胞；干细胞诱导；干细胞分化；组织工程

Key words: Tissue Engineering, Femur Head Necrosis, Femur

CLC Number:

R394.2

Ma Ning, Wang Hong-xia, Lu Qiang, Chen Si, Wan Yi-qun, Liu Ying-ying, Wang Xin, Peng Jiang, Guo Quan-yi. Local administration of mononuclear cell, platelet-rich plasma and zoledronic acid for the prevention and treatment of early femoral head osteonecrosis and collapse: study protocol for a prospective, randomized, parallel, controlled clinical trial[J]. Chinese Journal of Tissue Engineering Research, 2017, 21(33): 5388-5393.

Figures/Tables 1

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