Arthritis of Knee Clinical Trial
Official title:
Patient Matched Osteotomy to Correct Angular Deformities in Knee Arthrosis
For participants whose leg bones don't line up properly, extra stress is placed on either the
inner or outer side of the knee joint due to uneven transfer of body-weight. Gradually, this
extra pressure wears away the smooth cartilage, resulting in osteoarthritis on that side of
the knee joint. This problem is particularly common in young athletes and places them at risk
of early osteoarthritis.
An operation exists whereby one of the bones either side of the knee is cut ( an osteotomy)
and hinged open to straighten the leg. This alteration redistributes body-weight more equally
across the knee joint and is known to be effective in delaying and possibly preventing, the
progression of knee osteoarthritis- especially in younger and physically more active patients
in whom a knee replacement is undesirable.
Currently it is possible to ( accurately) calculate the precise position of the bone cut and
number of degrees correction required to straighten a leg using digital x-rays and
three-dimensional CT scans. However there is no method of implementing this pre-operative
plan during surgery so that the majority of surgeons rely on relatively crude and ipso facto
unreliable intra-operative measurements as a guide.
To improve the accuracy of this operation, the investigator propose the use of a custom-made
'cutting block', tailored for each individual patient and its shape will match the contour of
the patient's bone to ensure it can only be placed in one position. Pre-cut slots and holes
will then guide the saw cut and the number of degrees the bone in hinged open, as per the
pre-operative plan; it functions as an intra-operative template for the surgeon.
This study will primarily examine whether there is a close match between the planned and
actual correction of leg deformities when using a patient-matched cutting-block.
Malalignment of the leg is known to play a significant role in the development of knee
arthrosis. Osteotomy can be used to correct angular deformities around the knee. A number of
studies have found that the success of this procedure in delaying the progression of knee
arthrosis is highly dependent on an accurate of deformity correction.
It is possible to produce a precise pre-operative surgical plan of the osteotomy required for
a favourable outcome. However, the majority of surgeons still rely upon relatively crude and
ipso facto unreliable intra-operative measurements to guide the actual operation. This is
reflected in studies comparing the pre-operative plan with final outcome.
So to facilitate accurate translation of pre-operative osteotomy planning to intra-operative
execution, the investigator proposes to transfer two technologies that are already
commercially available in arthroplasty into the filed of corrective osteotomy i.e. 3D
planning and custom-made patient-matched cutting blocks. This will permit translation of the
surgeon's pre-order to ensure precise intra-operative positioning. Once secured slots and
holes in the cutting block will ensure that the bony cut and angular correction is performed,
and secured with a plate and screws, in the precise location determined by the pre-operative
plan.
A prospective multi centre study is proposed, primarily to confirm the efficacy of use, and
accuracy of deformity correction around the knee using patient-matched cutting blocks.
Accuracy will be assessed by comparing post-operative alignment (measured on plan radiographs
and CT scan) with the pre-operative surgical plan. Patient questionnaires to assess outcome
will also be collected, and optional gait analysis performed.
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