Vibration therapy as an intervention for enhancing trochanteric hip fracture healing in elderly patients: a randomized double-blinded, placebo-controlled clinical trial

Ronald Man Yeung Wong, Simon Kwoon Ho Chow, Ning Tang, Yik Lok Chung, James Griffith, Wing Hong Liu, Raymond Wai Kit Ng, Chi Yin Tso, Wing Hoi Cheung, Ronald Man Yeung Wong, Simon Kwoon Ho Chow, Ning Tang, Yik Lok Chung, James Griffith, Wing Hong Liu, Raymond Wai Kit Ng, Chi Yin Tso, Wing Hoi Cheung

Abstract

Background: There are more than 300,000 hip fractures yearly in the USA with mortality rates of 20% within 1 year. The treatment of osteoporotic fractures is a major challenge as bone quality is poor, and healing is expected to delay due to the impaired healing properties with respect to bone formation, angiogenesis, and mineralization. Enhancement of osteoporotic fracture healing and function is therefore critical as a major goal in modern fracture management. Previous pre-clinical studies have shown that low-magnitude high-frequency vibration (LMHFV) accelerates osteoporotic fracture healing. The objective of this study is to investigate the effect of LMHFV on accelerating trochanteric hip fracture healing and functional recovery.

Methods: This is a randomized, double-blinded, placebo-controlled clinical trial to evaluate the effect of LMHFV in accelerating trochanteric hip fracture healing. All fractures undergo cephalomedullary nail fixation. The primary outcome of this study is time to fracture healing by X-ray. Computed tomography (CT) and dual-energy X-ray absorptiometry (DXA) will also be performed. Blood circulation at the fracture site will be assessed by dynamic perfusion magnetic resonance (MR). Clinical results include functional recovery by muscle strength, timed up and go test (TUG), quality of life questionnaire (SF-36), balancing, falls, and mortality.

Discussion: Previous animal studies have demonstrated LMHFV to improve both normal and osteoporotic fracture healing by accelerating callus formation and mineralization. The mechanical stimulation stimulates angiogenesis by significantly enhancing vascular volume and blood flow velocity. This is the first study to translate LMHFV to enhancing hip fracture healing clinically. Positive results would provide a huge impact in the recovery of hip fracture patients and save healthcare costs.

Trial registration: Clinicaltrials.gov NCT04063891. Registered on August 21, 2019.

Keywords: Hip fractures; Osteoporosis; Randomized controlled trial; Trochanteric fracture; Vibration treatment.

Conflict of interest statement

All authors declared we have no conflict of interest in this study. All authors give their consent for publication. Data and materials can be considered to be shared upon request to the corresponding author. The study is funded by the General Research Fund Early Career Scheme, HKSAR Research Grant Council (Ref: 24108519).

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
A flowchart of the study design. The Consolidated Standards of Reporting Trials (CONSORT) checklist is provided as Additional file 1; the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist is presented in Additional file 2

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Source: PubMed

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