Condition category
Injury, Occupational Diseases, Poisoning
Date applied
07/09/2008
Date assigned
18/09/2008
Last edited
18/09/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julia Seifert, MD PhD

ORCID ID

Contact details

Department of Trauma and Orthopaedic Surgery
Unfallkrankenhaus Berlin
Berlin
12683
Germany
julia.seifert@ukb.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PUSH-IT V1.3 08/08

Study information

Scientific title

Acronym

PUSH-IT

Study hypothesis

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

The Institutional Review Board (IRB) of the Charité University Medical Centre (Germany), dated 4th June 2008 (ref: EA1/079/08)

Study design

Pragmatic, randomised controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Bony union three months (+/- 1 week) after randomisation, as assessed on plain radiographs by independent, blinded raters.

Secondary outcome measures

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.

Overall trial start date

01/10/2008

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250 (O'Brien-Fleming adaptive design: RD 20%, alpha 0.025, power 83%, 2 x 106 patients, assumed drop-out rate 15%)

Participant exclusion criteria

1. Multiple injuries/polytrauma
2. Greater than I° open fractures
3. Pregnant or breastfeeding women
4. Pathological fractures

Recruitment start date

01/10/2008

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Trauma and Orthopaedic Surgery
Berlin
12683
Germany

Sponsor information

Organisation

German Employer's Liability Insurance for the Administrative Professions (Verwaltungs-Berufsgenossenschaft [VBG]) (Germany)

Sponsor details

Head Office
Department of Rehabilitation
Deelbögenkamp 4
Hamburg
22281
Germany
wolfgang.ebeling@vbg.de

Sponsor type

Government

Website

http://www.vbg.de/

Funders

Funder type

Government

Funder name

German Employer's Liability Insurance for the Administrative Professions (Verwaltungs-Berufsgenossenschaft [VBG]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes