Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. The effect of low intensity ultrasound and bioabsorbable self-reinforced poly-L-lactide screw fixation on bone in lateral malleolar fractures. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. The effect of pulsed ultrasound in the treatment of tibial stress fractures. The effects of extracorporeal shockwave on acute high-energy long bone fractures of the lower extremity. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. No effect of low-intensity ultrasound on healing time of intramedullary fixed tibial fractures. Effect of ultrasound therapy on bone healing of lateral malleolar fractures of the ankle joint fixed with bioabsorbable screws. [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.
A clinical study was conducted to investigate the effect of low-intensity pulsed ultrasound (US) stimulation (LIPUS) on the healing of complex tibial fractures. Thirty complex tibial fractures were randomly assigned to the treatment with LIPUS (n = 16) or by a dummy machine (sham-exposed: n = 14). The fractures were immobilized by either internal or external fixations according to the clinical indications. LIPUS was given 20 min/day for 90 days. Fracture healing was monitored by clinical, radiological, densitometric and biochemical assessments. The LIPUS-treated group showed statistically significantly better healing, as demonstrated by all assessments. Complications were minimal in the LIPUS group. There were two cases of delayed union, with one in each group. There were two cases of infection in the control group. The delayed-union cases were subsequently treated by LIPUS and the infection cases were treated with standard protocol. Fracture healing in these patients was again treated by LIPUS. 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. 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. 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. High-energy long bone fractures of the lower extremity are at risk of poor fracture healing and high rate of non-union. Extracorporeal shockwave was shown effective to heal non-union of long bone fracture. However, the effect of shockwave on acute fractures is unknown. The purpose of this study was to investigate the effects of shockwave on acute high-energy fractures of the lower extremity.
                Between January and October 2004, 56 patients with 59 acute high-energy fractures were enrolled in this study. Patients were randomly divided into two groups with 28 patients with 28 fractures in the study group and 28 patients with 31 fractures in the control group. Both groups showed similar age, gender, type of fracture and follow-up time. Patients in the study group received open reduction and internal fixation and shockwave treatment immediately after surgery on odd-numbered days of the week, whereas, patients in the control group received open reduction and internal fixation without shockwave treatment on even-numbered days of the week. Postoperative managements were similarly performed in both groups including crutch walking with non-weight bearing on the affected limb until fracture healing shown on radiographs. The evaluation parameters included clinical assessments of pain score and weight bearing status of the affected leg and serial radiographs at 3, 6 and 12 months. The primary end-point is the rate of non-union at 12 months, and the secondary end point is the rate of fracture healing at 3, 6 and 12 months.
                At 12 months, the rate of non-union was 11% for the study group versus 20% for the control group (P < 0.001). Significantly, better rate of fracture healing was noted in the study group than the control group at 3, 6 and 12 months (P < 0.001).
                Extracorporeal shockwave is effective on promoting fracture healing and decreasing the rate of non-union in acute high-energy fractures of the lower extremity. 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. To determine whether stimulation with low-intensity ultrasound will reduce the radiologic healing time of fresh tibial shaft fractures fixed with a reamed and statically locked intramedullary rod.
                Prospective, randomized, double blinded, and placebo controlled.
                Thirty-two adult patients were included, fifteen in the active ultrasound group and seventeen in the placebo group. They all used an ultrasound device twenty minutes daily for seventy-five days without knowing whether it was active or inactive. Standardized radiographs were taken every third week until healing and at six and twelve months. All radiographs were assessed blinded and independently by a radiologist and an orthopaedic surgeon. The codes were not broken until all fractures had healed and all radiographs had been evaluated.
                The time until the first visible callus averaged 40+/-3 days for the active group and 37+/-3 days for the placebo (p=0.44). The healing time, defined as radiologic bridging of three cortices, was on average 155+/-22 days (median 113 days) for the active treatment group and 125+/-11 days (median 112 days) for the placebo group (p=0.76) as assessed by the radiologist and 128+/-13 days for the active group and 114+/-9 days for the placebo group (p=0.40) as evaluated by the orthopaedic surgeon.
                We conclude that low-intensity ultrasound treatment did not shorten healing time in fresh tibial fractures treated with a reamed and statically locked intramedullary nail. Our results are not in accordance with previous findings reporting reduced healing time in nonoperatively treated tibial shaft fractures when subjected to ultrasound. 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. 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.
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.