Vibration therapy as an intervention for enhancing trochanteric hip fracture healing in elderly patients

Vibration therapy as an intervention for enhancing trochanteric hip fracture healing in elderly patients:

• a randomized double-blinded, placebo-controlled clinical trial.

Prepared on the basis of:

Vibration therapy as an intervention for enhancing trochanteric hip fracture healing in elderly patients: a randomized double-blinded, placebo-controlled clinical trial. Wong R.M.Y., Chow S.K.H., Tang N. et al. Trials. 2021 Dec 4;22(1):878

The authors present a randomized, double-blinded, placebo-controlled clinical trial to evaluate the effects of LMHFV in accelerating trochanteric hip fracture healing after fracture cephalomedullary nail fixation. Time to fracture healing by X-ray is a primary outcome of the study. Additional assessments include CT, DXA, and dynamic perfusion MR. Clinical results will be assessed by muscle strength, timed up and go test (TUG), quality of life questionnaire (SF-36), balancing, falls, and mortality.

Introduction

Hip fractures are currently ranked as the top 10 causes of disability. The leading cause is osteoporosis and the lifetime fracture risk of osteoporotic patients reaches as high as 40%. 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. Low-magnitude high-frequency vibration (LMHFV) is a promising biophysical intervention that provides non-invasive, systemic mechanical stimulation. Previous animal studies have demonstrated LMHFV to improve both normal and osteoporotic fracture healing by accelerating callus formation and mineralization. The aim is to translate the use of LMHFV to enhancing hip fracture healing in clinical patients. The study is to assess the efficacy of LMHFV in accelerating trochanteric hip fracture healing. The primary outcome is fracture healing. The secondary outcomes are densitometry, circulation, function, pain, quality of life, falls, and mortality.

• The study is a randomized, double-blind, placebo-controlled study in elderly patients aged 65 years or older.
• The objective of the study is to investigate the effect of LMHFV on accelerating trochanteric hip fracture healing and functional recovery.
• Positive study results would provide a huge impact in the recovery of hip fracture patients and save healthcare costs.

Status and conclusions

This trial was planned to evaluate the effect of LMHFV (VH-001 exercise platform; V-health Limited, Hong Kong) on accelerating trochanteric hip fracture healing. The completion of the trial is expected to take 24 months. Enrolment in the trial was planned to begin in January 2021, however due to the COVID-19 situation, the trial started later, in September 2021.
Trochanteric hip fracture patients admitted to the Orthopaedics and Traumatology ward are recruited, who arrive from the Prince of Wales Hospital affiliated with the Chinese University of Hong Kong. All patients will be screened for the inclusion and exclusion criteria to meet eligibility for the study. Closed reduction and cephalomedullary nail fixation (Gamma3 nail, Stryker, USA) will be performed within 48 hrs from admission. Each subject will be provided with orthogeriatric co-care. Before surgery, cefazolin 1 g will be given and continued for 3 doses after every 8h. Full weight bearing with physiotherapy will be started as soon as patient condition allows.
The study enrolment criteria call for elderly subjects, aged 65 years or more, with unilateral trochanteric hip fractures. The total planned sample size is 120. Outcomes will be assessed by radiographs, CT, clinical monitoring, BMD/BMC, MR, questionnaires, quadriceps muscle strength, balancing ability, TUG test, falls, and mortality.

More in: