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- Klinische proef NCT02581605
Correction of Angular Deformities in Knee Arthrosis
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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London, Verenigd Koninkrijk, W6 RF
- Charing Cross Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Osteotomy Arm:
Target population: 42
Partial Knee Replacement Arm:
Target population: 42
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Osteotomy Arm
Patients due to undergo an osteotomy around the knee.
To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient.
|
To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient.
|
Partial Knee Replacement Arm
Patients due to undergo a partial knee replacement.
To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient.
|
To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Final radiographic alignment is with two degrees of pre-operative plan in both coronal and sagittal
Tijdsspanne: 24 months
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24 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Professor Justin Cobb, Imperial College London
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13/LO/1639
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