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Prophylactic Reinforcement of Osteoporotic Bone in Elderly.

Prophylactic Reinforcement of Osteoporotic Bone in Elderly.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24464
Enrollment
100
Registered
2009-03-27
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with a fresh, low energy, fracture of the hip heupfracturen preventie osteoporose

Interventions

Injection with butyl/methyl methylacrylate, containing iodine in the healthy hip, using a 10 mm hole in the trochanteric region.

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Hip fracture.

Secondary

MeasureTime frame
1. Pain (VAS); 2. Efficacy; 3. Radiographic and densitometric; 4. Assessment of bone regeneration after two years.

Contacts

Public ContactP.R.G. Brink

Postbox 25

p.brink@mumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)