Effect of ultrasound therapy on bone healing of lateral malleolar fractures of the ankle joint fixed with bioabsorbable screws. The effect of low intensity ultrasound and bioabsorbable self-reinforced poly-L-lactide screw fixation on bone in lateral malleolar fractures. No long-term effects of ultrasound therapy on bioabsorbable screw-fixed lateral malleolar fracture. Randomized controlled study of ultrasound therapy in the management of acute lateral ligament sprains of the ankle joint. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. [Does low intensity, pulsed ultrasound speed healing of scaphoid fractures?]. Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: a multi-centre double blind randomised controlled trial. The effect of pulsed ultrasound in the treatment of tibial stress fractures. Anti-inflammatory effects of ultrasound therapy: evidence for a major placebo effect.
We investigated the effect of low-intensity ultrasound on bone healing in bioabsorbable self-reinforced poly-L: -lactic acid (SR-PLLA) screw-fixed lateral malleolar fractures. The study design was prospective, randomized, double-blind, and placebo-controlled.
                A total of 22 fractures were fixed with one SR-PLLA screw. All the patients were instructed to use an ultrasound device 20 min daily for 42 days without knowing whether it was active or inactive. Eleven patients had active and eleven sham ultrasound devices. The causes of error during treatment with head module placement and attachment to the convex surface of the lateral distal fibula were minimized by careful targeting and using coupling gel. Radiological fracture healing was assessed by radiographs and multidetector computed tomography (CT) scans in a blinded manner by a radiologist and orthopedic surgeons.
                The overall compliance to the daily ultrasound treatments was good. All wounds healed uneventfully, and no foreign body reactions were observed. No difference was observed between the groups regarding either fracture line visualization or callus formation assessed by plain radiographs. In the CT images at 9 weeks, the share of the endosteal united fracture line compared to the non-united fracture line was slightly higher in the active ultrasound device group than in the sham ultrasound device group, but the difference was not statistically significant.
                The study indicates that the biocompatibility of ultrasound therapy and bioabsorbable SR-PLLA screw fixation is good. There was no obvious effect of low-intensity ultrasound on lateral malleolar fracture healing. However, the relatively small number of patients must be kept in mind when interpreting our results. It is also important to limit any conclusions based on the present study to malleolar fractures fixed with the SR-PLLA screw. There are no previous reports of low intensity pulsed ultrasound therapy in connection with bioabsorbable fracture fixation. In this randomised, prospective, double-blind and placebo-controlled study, the effects of ultrasound on bone mineral density and bone healing were examined in lateral malleolar fractures fixed with a bioabsorbable self-reinforced poly-L-lactide screw (SR-PLLA).
                Thirty adult patients with SR-PLLA screw-fixed lateral malleolar fracture underwent ultrasound therapy 20 min daily for 6 weeks. Half of the patients were provided randomly with a sham ultrasound device. Bone mineral density and bone healing were assessed by dual-energy X-ray absorptiometry (DXA) and by radiographs.
                Bone mineral density of the fractured lateral malleolus tended to increase slightly during 12 weeks of follow-up. The increase was symmetrical and statistically non-significant between the ultrasound and non-ultrasound group. All the fractures healed uneventfully. The biocompatibility of the bioabsorbable SR-PLLA fixation device and low intensity pulsed ultrasound was good. Despite the slight tendency for more frequent callus formation in the ultrasound group, no statistically significant effect of low intensity pulsed ultrasound on lateral malleolar fracture healing could be observed.
                It was not possible to observe any statistically significant effect of low intensity pulsed ultrasound on lateral malleolar fracture healing in this study. Further studies are needed to examine the role of ultrasound therapy in the healing of fractures treated with bioabsorbable fixation devices. The present study was initiated to evaluate the long-term effects of low-intensity ultrasound therapy on bioabsorbable screw-fixed lateral malleolar fractures, which has not been studied earlier.
                The study design was prospective, randomized, double-blinded, and placebo-controlled. Sixteen dislocated lateral malleolar fractures were fixed with one bioabsorbable self-reinforced poly-L-lactide screw. The patients used an ultrasound device 20 minutes daily for six weeks without knowing it was active (eight patients) or inactive (eight patients). The follow-up time was 18 months. The radiological bone morphology was assessed by multidetector computed tomography (MDCT) scans, the bone mineral density by dual-energy X-ray absorptiometry scans, and the clinical outcome by Olerud-Molander scoring and clinical examination of the ankle.
                The MDCT scans revealed that all fractures were fully healed, and no differences were observed in radiological bone morphology at the fracture site. The bone mineral density of the fractured lateral malleolus tended to increase slightly during the 18-month follow-up, the increase being symmetrical in both groups. No differences were observed in the clinical outcome or Olerud-Molander scores.
                The six-week low-intensity ultrasound therapy had no effect on radiological bone morphology, bone mineral density or clinical outcome in bioabsorbable screw-fixed lateral malleolar fractures 18 months after the injury. To determine the efficacy of a fixed dose of ultrasound energy to treat acute lateral ligament sprains of the ankle joint.
                Double-blind randomised controlled trial.
                Accident and Emergency department of University Teaching Hospital.
                Patients presenting at Accident and Emergency with ankle injuries.
                Ultrasound or placebo, and Tubigrip.
                Pain measured with visual analogue scales, swelling using a tape measure, range of movement using a fluid-filled goniometer, and weight bearing using two scales simultaneously.
                Patients in both groups improved symptomatically. There were no statistically significant differences between groups in any outcome measure. Within groups, statistically significant differences were detected in pain perceived, and range of movement (dorsiflexion).
                At the dose and duration used, ultrasound therapy is no better than placebo in the management of lateral ligament injuries. Sixty-seven closed or grade-I open fractures of the tibial shaft were examined in a prospective, randomized, double-blind evaluation of use of a new ultrasound stimulating device as an adjunct to conventional treatment with a cast. Thirty-three fractures were treated with the active device and thirty-four, with a placebo control device. At the end of the treatment, there was a statistically significant decrease in the time to clinical healing (86 +/- 5.8 days in the active-treatment group compared with 114 +/- 10.4 days in the control group) (p = 0.01) and also a significant decrease in the time to over-all (clinical and radiographic) healing (96 +/- 4.9 days in the active-treatment group compared with 154 +/- 13.7 days in the control group) (p = 0.0001). The patients' compliance with the use of the device was excellent, and there were no serious complications related to its use. This study confirms earlier animal and clinical studies that demonstrated the efficacy of low-intensity ultrasound stimulation in the acceleration of the normal fracture-repair process. A multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to test the efficacy of a specifically programmed, low-intensity, non-thermal, pulsed ultrasound medical device for shortening the time to radiographic healing of dorsally angulated fractures (negative volar angulation) of the distal aspect of the radius that had been treated with manipulation and a cast. Sixty patients (sixty-one fractures) were enrolled in the study within seven days after the fracture. The patients used either an active ultrasound device (thirty fractures) or a placebo device (thirty-one fractures) daily for twenty minutes at home for ten weeks. The two types of devices were identical except that the placebo devices emitted no ultrasound energy. Clinical examination was performed and radiographs were made at one, two, three, four, five, six, eight, ten, twelve, and sixteen weeks after the fracture by each site investigator. The time to union was significantly shorter for the fractures that were treated with ultrasound than it was for those that were treated with the placebo (mean [and standard error], 61 +/- 3 days compared with 98 +/- 5 days; p < 0.0001). Each radiographic stage of healing also was significantly accelerated in the group that was treated with ultrasound as compared with that treated with the placebo. Compared with treatment with the placebo, treatment with ultrasound was associated with a significantly smaller loss of reduction (20 +/- 6 per cent compared with 43 +/- 8 per cent; p < 0.01), as determined by the degree of volar angulation, as well as with a significant decrease in the mean time until the loss of reduction ceased (12 +/- 4 days compared with 25 +/- 4 days; p < 0.04). We concluded that this specific ultrasound signal accelerates the healing of fractures of the distal radial metaphysis and decreases the loss of reduction during fracture-healing. Since pulsed low-intensity ultrasound (frequency: 1.5 MHz, pulsed by 1 kHz, signal burst width: 200 microseconds, intensity: 30 mW/cm2) has been proven to stimulate fracture healing both clinically and experimentally, our question was whether this therapy also accelerates healing of fresh stable scaphoid fractures. Addressing this question, we did the following prospective randomized clinical trial. Regarding the results of former clinical fresh fracture studies by Heckman and Kristiansen, we postulated that low intensity ultrasound accelerates healing by about 30%. Based on this thesis, we calculated that 30 patients divided into two groups would be necessary to show significant differences between the standard treatment (treated by casting) and an adjunctive ultrasound treatment (treated by casting and additional daily 20 minutes ultrasound treatment) if present. Diagnosis and healing was assessed by CT scans every two weeks. CT's were analyzed by two independent radiologists and one hand surgeon. Furthermore, areas of cancellous bone bridging in correlation to the diameter of the scaphoid was measured in each CT scan. The results showed ultrasounded fractures healing in 43.2 +/- 10.9 days versus 62 +/- 19.2 days in the control group (p < 0.01). Trabecular bridging six weeks after injury showed 81.2% +/- 10.4% healed in the ultrasound-stimulated fractures versus 54.6% +/- 29% in the control (p < 0.05). Our study results confirm those of Heckman and Kristiansen and show a similar acceleration of bone healing. Low intensity ultrasound is successful in accelerating the healing of fresh scaphoid fractures. Several randomised trials have been published on the effect of low-intensity pulsed ultrasound (LIPUS) on fracture healing in both distal radius and tibia fractures. Most studies showed a positive effect on time to clinical and radiological healing. We hypothesised that LIPUS has a beneficial effect on the healing of fresh clavicle fractures as well and studied its effect in non-operatively treated shaft fractures.
                We conducted a randomised double blind, placebo-controlled multi-centre trial in 101 adult patients with a non-operatively treated fresh clavicle shaft fracture. Of these patients, 49 used a placebo transducer and 52 patients had an active transducer with ultrasound stimulation (Exogen 2000). Data were analysed on intention to treat basis. Baseline parameters of both groups were not significantly different.
                There were no differences in time to subjective clinical fracture healing, resumption of daily activities, sports or professional work, Visual Analogue pain Scores (VAS) and use of pain medication.
                Our findings did not confirm that LIPUS accelerates clinical healing time of fresh clavicle shaft fractures.
                Level 1 evidence that low-intensity pulsed ultrasound does not accelerate clinical fracture healing in non-operatively treated fresh midshaft clavicle fractures. Tibial stress fractures commonly occur in athletes and military recruits. This prospective, randomized, double-blind clinical study sought to determine whether pulsed ultrasound reduces tibial stress fracture healing time. Twenty-six midshipmen (43 tibial stress fractures) were randomized to pulsed ultrasound or placebo treatment. Twenty-minute daily treatments continued until patients were asymptomatic with signs of healing on plain radiographs. The groups were not significantly different in demographics, delay from symptom onset to diagnosis, missed treatment days, total number of treatments, or time to return to duty. Pulsed ultrasound did not significantly reduce the healing time for tibial stress fractures. The value of therapeutic ultrasound (US) for reducing inflammation was tested in a double-blind controlled study in 150 patients following surgical removal of impacted lower third molars. Facial swelling, trismus, pain and serum C-reactive protein (CRP) were significantly reduced in the US-treated groups and in a placebo group ('mock' US) compared with an untreated control group. The majority of the anti-inflammatory activity was attributable to the placebo effect, and the highest intensity of US (1.5 W.cm-2) was consistently less beneficial than the lower intensities (0.1 and 0.5 W.cm-2) and the mock US.
While a potential benefit of ultrasound for the treatment of acute fractures in adults cannot be ruled out, the currently available evidence from a set of clinically heterogeneous trials is insufficient to support the routine use of this intervention in clinical practice. Future trials should record functional outcomes and follow-up all trial participants.