ABSTRACT
OBJECTIVE: Despite advances in treatment, the management of fracture non-union remains a challenging and complex problem in orthopaedics. Low-intensity pulsed ultrasound (LIPUS) treatment has been shown to be an effective, non-invasive, affordable treatment option. This treatment was evaluated in a Scottish district hospital over a nine-year period, which included the COVID-19 pandemic. MATERIALS AND METHODS: This submission describes a case series at Dr Gray's Hospital in Scotland, 18 patients in whom fracture non-union was treated using LIPUS. RESULTS: An overall healing rate of 94% was achieved. Exogen™ (Bioventus LLC, NC, USA) proved to be most successful in oligotrophic non-union. No observed patient demographic appeared predictive of outcome. LIPUS treatment failed in one case. No significant adverse effects of LIPUS were detected. CONCLUSION: LIPUS represents a useful, cost-effective potential alternative to revision surgery. LIPUS may therefore be the preferred treatment when surgical intervention and face-to-face interactions are to be minimised, as during the COVID-19 pandemic.
ABSTRACT
Background Fracture non-union can lead to significant patient morbidity with poor quality of life. Due to the cost, complexity, and potential risks of revision surgery, there has been an increased popularity in the use of low-intensity pulsed ultrasound therapy (LIPUS), which accelerates and promotes bone consolidation. There is an ongoing debate regarding the use and efficacy of LIPUS in delayed union and non-union. This study aims to assess the success rate of LIPUS therapy in patients treated for delayed and non-union fractures, explicitly focusing on the impact of patient co-morbidities and fracture characteristics. Method A retrospective observational study was performed of all consecutive patients who received LIPUS therapy in a single institution from January 2016 to September 2022. Of 127 identified patients, only 99 patients met our inclusion criteria. Data collection entailed reviewing the clinical notes to assess patients' sex, age, co-morbidities, initial treatment method, time to initiate LIPUS, whether a CT was performed to diagnose non-union, time to union and whether revision surgery was needed. Two independent senior orthopedic doctors reviewed the patients' radiographs, measured the interfragmentary bone gap of all fractures, and assessed whether the radiographic union was achieved. Results The mean age of the included patients was 52.5 (SD±16.9) years with a male-to-female ratio of 1:1.6. At initial presentation, 65 (out of 99) patients were treated surgically, whereas the rest were managed conservatively. 80.8% of patients developed atrophic non-union. All 99 included patients were fitted with LIPUS once delayed/ non-union was diagnosed; the average time to fitting was 5.1 (SD±3.9) months. Of these, 61.6% of patients were successfully treated with LIPUS with a clinical and radiological union at an average of 4.3 (SD±1.9) months. The rest of the patients needed further surgical intervention due to ongoing non-union. The interfragmentary bone gap was the only statistically significant factor influencing the success of LIPUS therapy (p=0.003). In contrast, no statistically significant association was identified between the outcome of LIPUS therapy and the patient's age, sex, diabetes, and smoking status. Conclusion This study demonstrated a 61.6% progression to union rate of patients treated with LIPUS therapy for delayed union and non-union. The interfragmentary bone gap was identified as the only statistically significant factor influencing the success of LIPUS therapy. In the current climate post-lockdown and with ongoing Covid 19 outbreaks impacting elective waiting lists negatively, there is increased value and demand for non-surgical treatment options. LIPUS therapy represents an important complementary non-surgical and low-risk treatment pathway for delayed union and non-union.
ABSTRACT
The prevalence of Alzheimer's disease (AD) has been rapidly increasing worldwide. We have developed a novel angiogenic therapy with low-intensity pulsed ultrasound (LIPUS), which is effective and safe in animal models of AD and vascular dementia. We performed two trials of LIPUS therapy for AD (mild cognitive impairment due to AD and mild AD); a roll-in open trial for safety, and a randomized, double-blind, placebo-controlled (RCT) trial for efficacy and safety. The LIPUS therapy was performed for whole brain through the bilateral temporal bones for one hour 3 times a week as one session under the special conditions (1.3 MPa, 32 cycles, 5% duty cycle) we identified. The LIPUS therapy was performed for one session in the roll-in trial, and 6 sessions in the RCT trial with 3-month intervals for 1.5 years. The primary endpoint was ADAS-J cog scores. The RCT trial was terminated prematurely due to the COVID-19 pandemic. In the roll-in trial (N = 5), no adverse effects were noted. In the RCT trial (N = 22), the worsening of ADAS-J cog scores tended to be suppressed in the LIPUS group compared with the placebo group at week 72 (P = 0.257). When responders were defined as those with no worsening of ADAS-J cog scores at week 72, the prevalence was 50% (5/10) and 0% (0/5) in the LIPUS and placebo groups, respectively (P = 0.053). No adverse effects were noted. These results suggest that the LIPUS therapy is safe and tends to suppress cognitive impairment although a next pivotal trial with a large number of subjects is warranted.