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. 2023 Mar 3;2023(3):CD008579. doi: 10.1002/14651858.CD008579.pub4

Leung 2004.

Study characteristics
Methods Quasi‐randomised, placebo‐controlled study, parallel design.
Participants Setting: Chinese University of Hong Kong, China.
Study dates: September 1999 to April 2002.
Size: a total of 30 fractures in 28 participants.
Baseline characteristics (overall):

  • Age, mean (range): 35.3 (22 to 61) years

  • Gender, M/F: 25/3

  • Fracture site

    • Proximal: 4

    • Diaphyseal: 20

    • Distal: 8

  • Fracture type

    • Closed: 13

    • Open

      • Gustilo Anderson I: 5

      • Gustilo Anderson II: 7

      • Gustilo Anderson IIIa: 5


Baseline characteristics (treatment):

  • Open fracture/ closed fracture: 9/7

  • Surgical treatment

    • External fixator: 10

    • Intramedullary nail: 6


Baseline characteristics (control):

  • Open fracture/ closed fracture: 8/6

  • Surgical treatment

    • External fixator: 9

    • Intramedullary nail: 5


Inclusion criteria: people with open or comminuted tibial fractures.
Exclusion criteria: simple fractures, fractures of sites other than the tibia.
Interventions General surgical details: participants with closed fractures or Gustilo grade 1 or 2 open fractures in the diaphysis underwent fixation with reamed, locked intramedullary nail. Participants with fractures in the metaphysis or Gustilo grade 3 open fractures were treated with an external fixator. All open fractures were treated with emergency debridement and delayed closure.
Intervention details: LIPUS machine was given to the participants as soon as the soft tissues were closed. The ultrasound signal was composed of a 200 µs burst of 1.5 MHz sine waves, with a repetition rate of 1 kHz and a spatial average intensity of 30 mW/cm² and was given for 20 minutes a day, for 90 days using coupling gel applied directly over the fracture site.
Control details: a sham device that was externally identical to the LIPUS machine was given to the participants as soon as the soft tissues were closed.
Outcomes Reported outcomes and time points:
Follow‐up schedule: every 3 weeks for the first 3 months, every 6 weeks for the following 3 months and every 8 weeks for the last 6 months. End point was combined clinical and radiographic union. 
Primary outcome: time to union.
Secondary outcomes: bone mineral density and plasma bone specific alkaline phosphatase, adverse events.
Notes Funding: study funded by two industry sponsors (Exogen and Smith & Nephew) as well as the Hong Kong Research Grant Council
Conflict of Interest: no statement of conflict of interest in study manuscript.
Note: some participants had 2 fractures, and we could not be certain from the study report whether these were randomised separately.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "...assigned...according to the sequence of admission".
Comments: Quasi‐randomised.
Allocation concealment (selection bias) High risk Quote: "...assigned...according to the sequence of admission".
Comments: No list provided. Quasi‐randomised.
Blinding of participants and personnel (performance bias)
Objective measures High risk Quote: "Control group were given a dummy machine".
Comments: photos of the dummy machine show that the machine was not identical to the intervention machine
Blinding of outcome assessment (detection bias)
Objective measures Low risk Radiographs were assessed by independent surgeons
Incomplete outcome data (attrition bias) Low risk The complete dataset was presented
Selective reporting (reporting bias) Unclear risk No protocol or clinical trials register available
Other bias Low risk No other sources of bias identified