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. 2014 Jun;57(3):E105–E118. doi: 10.1503/cjs.010113

Table 1.

Description of studies

Trial Fracture location Fracture treatment Intervention and control therapy duration No. patients Age, mean ± SD yr Type of device (I: intervention; C: control)


LIPUS/ESTIM Control LIPUS/ESTIM Control
LIPUS trials

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

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

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

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

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

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

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

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

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

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

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

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

ESTIM trials

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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.