Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty
Status:
Unknown status
Trial end date:
2020-07-31
Target enrollment:
Participant gender:
Summary
Although hip replacement surgery is a successful way of dealing with the pain and immobility
caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10
years. The main reason for this is the development periprosthetic osteolysis, that is, loss
of bone around the site of the hip replacement. The osteolysis is thought to be due to the
small particles of debris worn from the surfaces of the hip implant. These particles cause a
reaction in the blood cells around the joint which in turn affects bone cells and leads to a
loss of bone around the implant. The joint implant will then eventually become loose and
unstable, a condition known as aseptic loosening. At present the only way to treat aseptic
loosening is to have another operation to secure the hip joint, known as revision surgery.
Revision surgery is not always successful and exposes the patient to the risk of major
surgery.
In this study we explore the potential for giving a medication (denosumab) that may prevent
the loss of bone around the hip replacement implant. We will recruit patients who have been
listed for revision surgery. One group of patients will be given a single dose of denosumabÍž
another group will be given a placebo (dummy drug). At the time of the revision surgery a
small sample of the bone from around the hip replacement will be taken and examined under the
microscope. Comparisons will be made between the patients having the denosumab and those
having placebo to find out whether the denosumab is having a beneficial effect on the bone
surfaces. If successful, this study will lead to further studies to develop the use of
denosumab to prevent aseptic loosening.