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Prophylactic Reinforcement of Osteoporotic Bone in Elderly.


- candidate number5520
- NTR NumberNTR1739
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2009
- Secondary IDsNL26919.068.09 
- Public TitleProphylactic Reinforcement of Osteoporotic Bone in Elderly.
- Scientific TitleProphylactic Reinforcement of Osteoporotic Bone in Elderly.
- ACRONYMPROBE
- hypothesisAugmentation 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.
- Healt Condition(s) or Problem(s) studiedOsteoporosis, Hip fractures
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2014
- Target number of participants100
- InterventionsInjection with butyl/methyl methylacrylate, containing iodine in the healthy hip, using a 10 mm hole in the trochanteric region.
- Primary outcomeHip fracture.
- Secondary outcome1. Pain (VAS);
2. Efficacy;
3. Radiographic and densitometric;
4. Assessment of bone regeneration after two years.
- Timepoints1. 2 years (investigation);
2. During lifetime (hip fracture).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. P.R.G. Brink
- CONTACT for SCIENTIFIC QUERIESProf. dr. P.R.G. Brink
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM), Stichting ST Annadal
- PublicationsN/A
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD27-mrt-2009 - 23-sep-2009


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