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

Published studies comparing morbidity/mortality and post-operative functional
outcome after cemented or uncemented hemi-arthroplasty are mostly
retrospective. So far no study has been published comparing the newer, commonly
used, hydroxy-apatite coated hemi-arthroplasty. The recent Cochrane Review on
this subject concludes that no definitive conlusions can be made and further
well-conducted randomised trials are required

The objective of this prospective randomised multi-center study is to compare
the clinical outcome of the cemented and hydroxy-apatite coated uncemented
hemi-arthroplasty for patients with a proximal intracapsular femoral fracture
and the indication of a hemi-arthroplasty.

Prospective, randomized, single-blinded study lasting 3 to 4 years (2-3 years
accrual and one year of follow-up).
The indicated patientgroup is defined as patients of 65 years or older with a
proximal intracapsular femoral fracture and the indication of a
hemi-arthroplasty.
After inclusion a Barthel index, Parker and Palmer mobility score, MMSE and DOS
questionnaire will be taken pre-operatively.
Blinded envelopes will be used to randomize between a cemented or
hydroxy-apetite coated uncemented hemi-arthroplasty. The patient and paramedics
will not be told which one of the two hemi-arthroplasty is placed.
During hospital stay the next variables will be recorded: mortality,
complications (infection, thrombosis, pulmonary embolism, CVA, delirium,
cardiac dysfunction/attack), mobilisation, pain (NRS), length of hospital stay
(medical indicated), DOS- and DOM-score, Barthel index and Parker and Palmer
mobility score at discharge.
Polyclinic controls will be after 6 weeks, 3 months and 1 year post-surgery.
Mortality, complications (infection, thrombosis, pulmonary embolism), pain
(NRS), Barthel index and Parker and Palmer mobility score will be recorded. An
X-ray of the hip will be made after 1 day, 3 months and 1 year post-surgery.

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.

Cemented or hydroxy-apatite coated uncemented hemi-arthroplasty are both
commonly accepted treatments.
If the patient does not want to participate in the study, he or she still has
to be treated with placement of (the same) hemi-arthroplasty.
Participation with this study does not imply extra burden or risks, except for
some questionarries, for the patient.