Randomised Clinical Trial comparing cemented and hydroxy-apatite coated uncemented hemi-arthroplasty in the elderly patient with a proximal intracapsular femoral fracture.

Randomised Clinical Trial comparing cemented and hydroxy-apatite coated uncemented hemi-arthroplasty in the elderly patient with a proximal intracapsular femoral fracture. - cemented versus hydroxy-apatite coated uncemented hemi-arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33945

Enrollment

400

Registered

2009-04-21

Start date

2009-09-17

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

broken hip proximal intracapsular femoral fracture

Interventions

Cemented versus hydroxy-apetite coated uncemented hemi-arthroplasty by patients of 65 years or older with a proximal intracapsular femoral fracture and the indication of a hemi-arthroplasty.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients from 65 years and older, who have an indication for a hemi-arthroplasty

Exclusion criteria

Exclusion criteria: Primary bone tumour or bone metastasis causing the proximal intracapsular femoral fracture Multiple trauma patient Patients suffering from coxarthrosis at the fractured side Revision of osteosyntesis

Design outcomes

Primary

Measure	Time frame
The primary outcome is a composite endpoint of Serious Adverse Events: mortality, cardiac arrest, clinically pulmonary embolism, myocard infarct and CVA.	—

Secondary

Measure	Time frame
Secundary study parameters are post-surgery delirium, complications and mobilisation. A cost-effectiveness analysis will be completed.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)