Pulsed Ultrasound to Speed-up Healing after Intramedullary nailing of Tibia fractures

ISRCTN	ISRCTN90844675
DOI	https://doi.org/10.1186/ISRCTN90844675
Protocol serial number	PUSH-IT V1.3 08/08
Sponsor	German Employer's Liability Insurance for the Administrative Professions (Verwaltungs-Berufsgenossenschaft [VBG]) (Germany)
Funder	German Employer's Liability Insurance for the Administrative Professions (Verwaltungs-Berufsgenossenschaft [VBG]) (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Julia Seifert, MD PhD
Scientific

Department of Trauma and Orthopaedic Surgery
Unfallkrankenhaus Berlin
Berlin
12683
Germany

Email	julia.seifert@ukb.de

Primary study design	Interventional
Study design	Pragmatic, randomised controlled multicentre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	PUSH-IT
Study objectives	Adjuvant pulsed ultrasound increases the bony union rate after three months from 20% to 40% after intramedullary nailing of tibia fractures compared to no adjuvant treatment.
Ethics approval(s)	The Institutional Review Board (IRB) of the Charité University Medical Centre (Germany), dated 4th June 2008 (ref: EA1/079/08)
Health condition(s) or problem(s) studied	Closed or I° open fractures of the tibia
Intervention	Experimental: pulsed, low-energetic ultrasound (Exogen, Smith & Nephew), applied daily for three months Control: standard of care The total duration of follow-up is one year after randomisation.
Intervention type	Other
Primary outcome measure(s)	Bony union three months (+/- 1 week) after randomisation, as assessed on plain radiographs by independent, blinded raters.
Key secondary outcome measure(s)	1. Delayed union and non-union rates 2. Health-related quality of life (36-item Short Form Health Survey [SF-36], EuroQoL instrument [EQ-5D]) 3. Functional outcomes (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) 4. Duration of sick leave 5. Cost-utility 6. Serious adverse events (SAE) Secondary outcomes will be assessed after 6 weeks, 3, 6, and 12 months.
Completion date	01/10/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	250
Key inclusion criteria	1. Men and women 2. Greater than 18 years old 3. With closed or I° open fractures of the tibia that had been treated by reamed or unreamed locking intramedullary nails less than 10 days prior to randomisation. Patients with fractures of the lateral malleolus, fixed by plates, as well as patients with minor concomitant injuries (bruises, sprains) will be offered trial participation.
Key exclusion criteria	1. Multiple injuries/polytrauma 2. Greater than I° open fractures 3. Pregnant or breastfeeding women 4. Pathological fractures
Date of first enrolment	01/10/2008
Date of final enrolment	01/10/2010

Department of Trauma and Orthopaedic Surgery

Berlin
12683
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes