Table 1.
Trial | Fracture location | Fracture treatment | Intervention and control therapy duration | No. patients | Age, mean ± SD yr | Type of device (I: intervention; C: control) | ||
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LIPUS/ESTIM | Control | LIPUS/ESTIM | Control | |||||
LIPUS trials | ||||||||
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Heckman et al.35 | Tibia | Closed reduction and above-knee casting. An alignment window was placed in the cast at the level of the fracture over the anteromedial aspect of the leg. Reduction of the casting to a below-knee cast; any subsequent splinting and weight bearing status was at the discretion of the clinician. | 20 min/d for 20 wk or until investigator believed fracture was healed sufficiently | 48 | 49 | 36 ± 2.3 | 31 ± 1.8 | I: Unidentified ultrasonography device C: Sham device |
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Kristiansen et al.36 | Radius | Closed reduction and immobilization of the limb in a cast with volar flexion and ulnar deviation. A window was created on the dorsal aspect of the cast overlying the fracture and a retaining alignment fixture was placed in the window. | 20 min/d for 10 wk | 40 | 45 | Not reported | Not reported | I: SAFHS 2A, Exogen Inc. C: Sham device |
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Emami et al.32* | Tibia | Reamed intramedullary nailing. | Started within 3 d after surgery, consisted of 20 min/d for 75 d; for max 25 h | 15 | 17 | 39.9 ± 16.2 | 34.3 ± 14 | I: SAFHS 2A, Exogen Inc. C: Sham device |
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Strauss et al.41* | 5th metatarsal | Short leg cast and weight bearing as tolerated for a mean of 10 d; all were converted to a hinged ankle foot orthosis and continued with weight bearing until fracture union. | 20 min/use, twice daily | 10 | 10 | Not reported | Not reported | I: Adjunctive active treatment with ultrasonography C: Standard care |
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Mayr et al.39* | Scaphoid | Forearm plaster splint was applied. After the swelling subsided a circular [arthrodesis] bandage replaced the splint and stayed on until the fracture was bridged. | 20 min/d | 15 | 15 | 37 ± 14† | 37 ± 14† | I: SAFHS R, Exogen Inc. C: Standard care |
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Leung et al.37* | Tibia | Closed fractures or Gustillo grade 1 or 2 open fractures in the diaphysis underwent fixation with reamed, locked intramedullary nail. Fractures in the metaphysis or Gustillo grade 3 open fractures were treated with an external fixator. All open fractures were treated with emergency débridement and delayed closure. |
20 min/d for 90 d | 16 | 14 | 35.3† | 35.3† | I: Exogen 2000_ device (Exogen, Smith & Nephew Inc.) C: Sham device |
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Rue et al.40 | Tibia | Protected weight bearing, alternative aerobic exercise, calcium and multivitamin supplements. | 20 min/d | 14 | 12 | 18.6 ± 0.8 | 18.4 ± 0.8 | I: Exogen Inc. C: Sham device |
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Handolin et al.33* | Malleolar | Fixed with a 4.5 mm self-reinforced poly-L-lactic acid screw placed anteriorly. The ankle was immobilized for 6 wk with a removable brace. | 20 min/d for 6 wk | 15 | 15 | 41.4 | 39.4 | I: SAFHS 2A, Exogen Inc. C: Sham device |
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Handolin et al.34* | Malleolar | Fixed with 1 anteriorly placed 4.5 mm self-reinforced poly-L-lactic acid, immobilized for 6 wk with a removable brace. | 20 min/d for 6 wk, beginning third postoperative week | 11 | 11 | 37.5 | 45.5 | I: SAFHS 2A; Exogen Inc. C: Sham device |
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Ricardo22 | Scaphoid | Initially immobilized with a long-arm thumb spica cast, followed by a short-arm cast until healing was demonstrated by radiograph. | 20 min/d | 10 | 11 | 26.7† | 26.7 | I: TheraMed 101-B bone-growth stimulator C: Ultrasonography device adjusted to give no signal output across the transducer |
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Lubbert et al.38* | Clavicle | Passive support with a collar and cuff for patients’ convenience as long as needed. | 20 min/d for 28 d | 61 | 59 | Not reported | Not reported | I: Exogen 2000 battery powered main operating unit and a treatment head module transducer (Smith and Nephew Inc.) C: Sham device |
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Yadav et al.42 | Tibia | Managed nonoperatively and prescribed paracetamol and ice packs. | 10 min/d | 39 | 28 | Not reported | Not reported | I: Conventional ultrasonography C: Sham device |
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ESTIM trials | ||||||||
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Barker et al.44* | Tibia | Full leg plaster immobilization, non–weight bearing. | 10 h/d for 24 wk | 9 | 7 | 38.0 ± 18.3 | 29.9 ± 8.0 | I: EM-S; circumferential coils fitted around the cast over fracture site. Pulse frequency: 15Hz. C: Inactive coil |
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Wahlström55 | Extra-articular distal radius | Immobilization alone. | 4 wk (use/d unknown) | 15 | 15 | 61.0 ± 4.3 | 60.8 ± 4.6 | I: Active EM-S; single copper wire placed outside of plaster over fracture. Pulse frequency: 1–1000Hz, Magnetic flux density: 4 gauss. C: As above, without EM-S unit |
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Poli et al.51 | Congenital pseudarthrosis | Surgically treated pseudarthrosis followed by cast immobilization for 3 mo then bracing with progression to weight bearing as tolerated. | 10 h/d for 52 wk | 6 | 6 | Not reported | Not reported | I: Active EM-S; 2 high-impedance coils. Pulse frequency: 75Hz, EMF force: 3.5mV. C: As above, without EM-S unit |
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Borsalino et al.47 | Femoral intertrochant eric wedge osteotomy to treat osteoarthritis | Surgery plus progression to weight bearing as tolerated over 90 d. | 8 h/d for 30 d | 15 | 16 | 56.5 ± 8.8 | 55.1 ± 8.2 | I: Active EM-S; Single coil generating EMF positioned on lateral side of femur. Pulse frequency: 75 Hz; EMF force: 2.5mV or 18 gauss C: Inactive device |
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Sharrard53* | Tibia | Full leg plaster cast with knee at 20–30º. | 12 h/d for 12 wk | 20 | 25 | 34.7 (range 18–84) | 45.4 (range 18–76) | I: EM-S; 2 enclosed external copper wires held over fracture site in Helmboltz configuration. Pulse frequency: 15Hz. C: Sham device |
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Mammi et al.50 | Tibial reduction osteotomy | Postoperation: above-knee cast immobilization and non–weight bearing for 30 d. | 8 h/d for 60 d | 18 | 19 | 62.9 ± 7.9 | 61.1 ± 9.5 | I: Active EM-S unit; EM-S held over cast by Velcro straps. Pulse frequency: 75Hz, EMF force: 3mV C: Sham device |
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Scott et al.52* | Any long bone | Immobilization and weight bearing as tolerated. | 25.4 wk (use/d unknown) | 10 | 11 | 40.6 ± 10.7 | 45.8 ± 20.5 | I: EM-S; 2 stainless steel disks placed over fracture site delivering sine-shaped EMF at frequency of 60000Hz. EMF force: 5–10V C: Sham device |
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Eyres et al.48 | Limb lengthening osteotomies | Surgery plus circular frame with 1mm of distraction/d. | 4 h/d over an average of 24.5 wk | 7 | 6 | 14.4 ± 3.9 | 13.7 ± 2.9 | I: Active EM-S Saddle-shaped coil placed in between proximal and distal fixator pins. Pulse frequency: 15Hz C: Sham device |
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Betti et al.46 | Femoral neck | Three cannulated screws followed by non-descriptive rehabilitation program. | 8 h/d for 90 d | 30 | 35 | 67.1 ± 6.0 Compliant patients only |
68.7 ± 6.0 | I: Active EM-S unit; commercially available pulsed EM-S unit. Pulse frequency: 75Hz, EMF force 3.5mV C: Sham device |
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Simonis et al.54* | Tibia | Fibular osteotomy and external fixator application with compression; non–weight bearing. | 14 h/d for 26 wk | 18 | 16 | 31.7 ± 14.6 | 32.3 ± 16.3 | I: EM-S; pulsed EM-s via 2 external coils in contact with skin held by crepe bandage. Pulse frequency: 23.3Hz, EMF force: 150V, Field intensity: 6A. C: Sham device |
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Beck et al.45 | Tibial stress fracture | Rest from activity plus calcium supplementation (500 mg/d calcium carbonate). | 15 h/d until stress fracture clinically healed | 22 | 21 | Not reported | Not reported | I: Active EM-S; commercially available stimulator unit delivering sinusoidal wave via 2 water-based gel electrodes. Pulse frequency 60Hz, EMF Force: 3–6V, Current: 5–10mA. C: Inactive device |
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Faldini et al.49* | Femoral neck | 3 cannulated screws followed by progressive weight bearing routine starting at 30 d. | 8 h/d for 90 d | 30 | 35 | 67.1 ± 6 compliant; 71.6 ± 3.1 non-compliant | 67.4 ± 6.9 compliant; 69.8 ± 5.2 non-compliant | I: Active EM-S unit; commercially available pulsed EM-S unit. Pulse frequency 75Hz, Peak Value: 2mT C: Sham device |
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Adie et al.43* | Tibia | Nonoperative or operative (Intramedullary nail, plate, or ex-fix) treatment with surgeon dictated rehabilitation. | 10 h/d for 12 wk | 106 | 112 | 38.5 | 39.7 | I: Active EM-S unit; commercially available pulsed EM-S unit (EBI Bone Healing System, Biomet Inc. C: Inactive device |
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Hanneman et al.20* | Acute scaphoid | Immobilization in a forearm cast with the first metacarpal and both phalanges immobilized. | 24 h/d | 24 | 29 | 44.3 | 37.7 | I: PEMF (Ossatec) bone growth stimulator C: Disabled PEMF bone growth stimulator (same device as intervention) |
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Shi et al.31* | Femur, tibia, humerus and radius/ulna | Surgical reduction and fixation of the fracture. | 8 h/d | 31 | 27 | 41 ± 14.5 | 38.4 ± 11.6 | I: Electromagnetic field delivered through a coil (Orthopulse II, OSSATEC) C: Sham signal generator from the same manufacturer |
EMF = electromagnetic force; ESTIM = electrical stimulation; LIPUS = low intensity pulsed ultrasonography; PEMF = pulsed electromagnetic field therapy; SAFHS = Sonic Accelerated Fracture Healing System; SD = standard deviation.
Analyzed quantitatively in the indirect comparison analysis.
Only the age for the full sample was reported, and was thus assumed to be the same for both intervention and control arm.