Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients

Summary

Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year. In Hong Kong, around 6,000 hip fractures occur yearly with costs approximately 52 million USD, and these numbers are projected to double by 2050.

The treatment of osteoporotic fractures is a major challenge as bone healing is delayed due to the impaired healing properties with respect to bone formation, angiogenesis and mineralization. Failure to unite results in pain, weakness, reduced mobility and fixation failure, and these complications are most common in elderly patients. Enhancement of osteoporotic fracture healing even after surgical fixation is therefore critical as a major goal in modern fracture management.

Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and we are the first group to study its effect on fracture healing. Our previous animal studies have shown LMHFV to enhance healing from the early inflammation stage to the late phases of remodeling in osteoporotic diaphyseal fracture healing. Using our newly developed clinically relevant metaphyseal fracture model, we further proved the efficacy of LMHFV. Our results show LMHFV significantly enhanced fracture healing in both osteoporotic and normal rats radiologically by X-ray and micro-CT, histologically and biomechanically.

Justified with our preclinical studies, we hypothesize LMHFV can accelerate the time to fracture healing and enhance functional recovery. In this study, we propose to study the efficacy of LMHFV in trochanteric hip fracture healing by conducting a randomized double-blinded placebo-controlled clinical trial. Elderly patients aged 65 years or older of either gender, after surgical fixation, will be treated with LMHFV at 35Hz, 0.3g, 20 minutes/day, 5 days/week for 6 months. Results will be evaluated by clinical assessments, radiologically with X-rays, Computed Tomography (CT) and dynamic perfusion Magnetic Resonance Imaging (MRI) for blood circulation evaluation, Dual-energy X-ray absorptiometry (DXA), functional outcomes, and mortality. Positive findings from the study would have huge impact and change clinical practice.

Conditions

• Hip Fractures

Interventions

DEVICE

Low-magnitude high-frequency vibration (LMHFV)

Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been reported to have no adverse effect.

DEVICE

Low-magnitude high-frequency vibration (LMHFV)

Placebo group will have sham treatment by standing on the LMHFV platform for 20 minutes/day

Sponsors & Collaborators

• Tai Po Hospital

  collaborator OTHER_GOV

• Prince of Wales Hospital, Shatin, Hong Kong

  lead OTHER

Principal Investigators

• Ronald Man Yeung Wong, MRCSEd, PhD · Chinese University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-06

Primary Completion

2024-09-06

Completion

2025-01-31

Countries

• Hong Kong

Study Locations