No registrations found.
ID
Source
Brief title
Health condition
patients with a fresh, low energy, fracture of the hip
heupfracturen
preventie
osteoporose
Sponsors and support
MUMC
Maastricht
Intervention
Outcome measures
Primary outcome
Hip fracture.
Secondary outcome
1. Pain (VAS);
2. Efficacy;
3. Radiographic and densitometric;
4. Assessment of bone regeneration after two years.
Background summary
This study will be the first clinical study concerning profylactic augmentation of the hip in patients with hip fractures in order to prevent an second hipfracture during lifetime.
Study objective
Augmentation of the contralateral hip in patients with a low energy hip fracture over 50Y willdecrease the change of a new hip fracture on the augemented side.
Study design
1. 2 years (investigation);
2. During lifetime (hip fracture).
Intervention
Injection with butyl/methyl methylacrylate, containing iodine in the healthy hip, using a 10 mm hole in the trochanteric region.
P.R.G. Brink
Department of Surgery MUMC
P.Debijelaan 25
Maastricht 6202 AZ
The Netherlands
p.brink@mumc.nl
P.R.G. Brink
Department of Surgery MUMC
P.Debijelaan 25
Maastricht 6202 AZ
The Netherlands
p.brink@mumc.nl
Inclusion criteria
1. Patient should have a low energy fracture of the hip at one side;
2. Age over 50;
3. The patient must be surgically and medically accepted for the femoroplasty operation;
4. The patient must have an expected life expectancy of 24 months or greater, as estimated by the physician in charge;
5. The patient must be able to understand sign a study specific informed consent prior to enrolment.
Exclusion criteria
1. The patient may not be estimated unsuitable for femoroplasty e.g. due to previous surgery;
2. Women, who are pregnant or are at risk of getting pregnant during the time of investigation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1641 |
| NTR-old | NTR1739 |
| CCMO | NL26919.068.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |