Arthritis of Knee Clinical Trial
Official title:
Patient Matched Osteotomy to Correct Angular Deformities in Knee Arthrosis
Verified date | March 2019 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 84 |
Est. completion date | December 2028 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Osteotomy Arm Inclusion Criteria: - All patients considered suitable candidates for an osteotomy around the knee. - All patients consenting to an osteotomy around the knee. - All patients considered medically fit for surgery. - All patients must be between 18 to 70 years of age. Exclusion Criteria: - Patients not suitable for an osteotomy around the knee. - Patients with collateral ligament(s) insufficiency. - Patients who decline surgery. - Patients lacking capacity to consent. - Patients who do not understand English (written and verbal). Partial Knee Replacement Arm: Inclusion Criteria - All patients considered suitable candidates for a partial knee replacement - All patients consenting to a partial knee replacement - All patients considered medically fit for surgery Exclusion Criteria - Patients not suitable for a partial knee replacement. - Patients who decline surgery. - Patients lacking capacity to consent. - Patients under the age of eighteen. - Patients who do not understand English (written and verbal). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Charing Cross Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Final radiographic alignment is with two degrees of pre-operative plan in both coronal and sagittal | 24 months |
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