Osteoarthritis Clinical Trial
Official title:
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge
The purpose of this study is to assess whether there is a difference between the TomoFix and Ellipse Intramedullary HTO Nail System in terms of bone regeneration in the tibial wedge by performing a CT-scan at 3 and 6-months postoperatively.
Malalignment of the knee joint causes arthritis in later life. Currently there are three
surgical ways to treat knee arthritis: total knee replacement, partial knee replacement, and
high tibial osteotomy (HTO). The former two very much focus on treating the effect of
malalignment, i.e. removing the arthritic joint. However, HTO addresses the cause of the
arthritis, namely the joint malalignment. This preserves the patient's joint and it means
that a patient will start using the unaffected part of the knee joint more.
HTO involves cutting a wedge out the tibia to correct the alignment of that bone with the
knee joint, to redistribute load from the affected medial part to lateral part. To keep the
tibia in the new position, a medical nail device is attached to keep it in place and allow
new bone to regenerate within the wedge. Currently, the market leader for HTO is the TomoFix
(by DePuySynthes company) plate and nail device. As the name suggests, TomoFix is fixed at
surgery and therefore the change in bone angle cannot be changed afterwards. It does mean
that patients can be weight-bearing on the affected leg soon after the HTO procedure. A new
CE-marked device is being tested in an interventional trial; it is produced by Ellipse
Technologies. This device is an extendable nail and inserted intramedullary; following
surgery the nail is tend slowly extended over a period of time until the bone correction is
satisfactory.
The CISKO imaging study will assess whether there is a difference between the TomoFix and
Ellipse system in terms of bone regeneration in the tibial wedge by performing a CT-scan at 3
and 6 months post-operatively. This will be quantified by two independent radiological
reports. A secondary objective is to investigate patient satisfaction and also patient pain
levels at these time intervals. The degree of bone healing is usually the main factor holding
clinicians back when it comes to advising patients on what activities they can return to
post-operatively. A difference in bone healing between the two systems may impact on the
advice clinicians can give patients regarding recommencing more intense activities such as
recreational sports, which ultimately could positively impact patients' health and
well-being.
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