Pulsed Ultrasound to Speed-up Healing after Intramedullary nailing of Tibia fractures
| ISRCTN | ISRCTN90844675 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90844675 |
| Secondary identifying numbers | PUSH-IT V1.3 08/08 |
- Submission date
- 07/09/2008
- Registration date
- 18/09/2008
- Last edited
- 18/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Contact information
Dr Julia Seifert, MD PhD
Scientific
Scientific
Department of Trauma and Orthopaedic Surgery
Unfallkrankenhaus Berlin
Berlin
12683
Germany
| julia.seifert@ukb.de |
Study information
| Study design | Pragmatic, randomised controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/10/2008 |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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%) |
| 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Trauma and Orthopaedic Surgery
Berlin
12683
Germany
12683
Germany
Sponsor information
German Employer's Liability Insurance for the Administrative Professions (Verwaltungs-Berufsgenossenschaft [VBG]) (Germany)
Government
Government
Head Office
Department of Rehabilitation
Deelbögenkamp 4
Hamburg
22281
Germany
| wolfgang.ebeling@vbg.de | |
| Website | http://www.vbg.de/ |
"ROR" |
https://ror.org/02gaw4292 |
Funders
Funder type
Government
German Employer's Liability Insurance for the Administrative Professions (Verwaltungs-Berufsgenossenschaft [VBG]) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
