Arthropathy of Hip Clinical Trial
Official title:
Prospective Randomised Control Trial to Compare the Effect Upon Bone Density and Clinical Outcomes When Using BoneMaster HA Coated Acetabular Cups Compared With Plasma Sprayed HA Coated Cups in Patients With Total Hip Replacements
The randomised controlled trial will be carried out on patients that require a total hip
replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint
to the bone is by coating the implant to encourage the body to grow bone onto the replacement
hip. This study is aiming to find out whether the new (Bonemaster) coating allows increased
bony growth onto the cup when compared to the usual (plasma-sprayed) coating. This may reduce
the incidence of early failures due to poor bony attachment, which is a well known
complication for early failure of total hip replacements.
The study will compare two different types of coating (BoneMaster and Plasma-sprayed) on the
cup of the replacement hip. Density of the bone immediately surrounding the cup will be
observed to see if there are differences between the two groups. The density of bone will be
measured using standard x−ray assessment and in a smaller sample of 14 patients, using a
special scan called Dual Energy X−ray Absorptiometry (DEXA Scan). Functional comparisons will
be assessed through clinical scores.
The patients will be identified by the orthopaedic surgeon in the orthopaedic clinic and
deemed suitable for the study if all inclusion and exclusion criteria are met. 210 patients
will be recruited to the study and each patient will be randomised into either of the groups
allowing 105 patients into each group. Patients will be followed up at 6 months, 1 year and 2
years after the surgery. All patients will have radiographic assessments at these follow-up
intervals, as well as Harris Hip, Oxford Hip and Womac scores. This will allow comparison of
the two groups.
The BoneMaster coating has been extensively tested in cell and animal studies and has been
evaluated in one previous clinical study and showed favorable results. Further investigation
is required to ensure the new coating may enhance bony growth allowing better fixation of the
hips in the early period after the operation and also over a longer period of time. The
growth needs to be measured using a more sensitive scan than radiographic assessment alone,
called DEXA which was also used in the previous study.
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