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Correction of Angular Deformities in Knee Arthrosis

12 maart 2019 bijgewerkt door: Imperial College London

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

Actief, niet wervend

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

Observationeel

Inschrijving (Verwacht)

84

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

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

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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
Final radiographic alignment is with two degrees of pre-operative plan in both coronal and sagittal
Tijdsspanne: 24 months
24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Professor Justin Cobb, Imperial College London

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2014

Primaire voltooiing (Verwacht)

1 december 2028

Studie voltooiing (Verwacht)

1 december 2028

Studieregistratiedata

Eerst ingediend

21 september 2015

Eerst ingediend dat voldeed aan de QC-criteria

20 oktober 2015

Eerst geplaatst (Schatting)

21 oktober 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 maart 2019

Laatste update ingediend die voldeed aan QC-criteria

12 maart 2019

Laatst geverifieerd

1 maart 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 13/LO/1639

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