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Correction of Angular Deformities in Knee Arthrosis

A legfontosabb adatok

Ki végzi
Imperial College London
Hol
Egyesült Királyság1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Fut, nem toboroz
Résztvevők
84 fő, tervezett
Kezdés
2014. nov.
Várható befejezés
2028. dec.
A vizsgálat típusa
Megfigyeléses, 2 csoport
A vizsgált kezelések
  • Custom-made 'cutting block'
A regiszteradat frissítve
2019. március 13.

Ki vehet részt

Életkor
18 év – 70 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 18 feltétel megnézéseKevesebb

Ki vehet részt

  • 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
  • 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)

Ki nem vehet részt

  • Patients who decline surgery
  • Patients with collateral ligament(s) insufficiency
  • Patients not suitable for an osteotomy around the knee
  • Patients lacking capacity to consent
  • Patients who do not understand English (written and verbal); Partial Knee Replacement Arm:

Egyéb feltételek

  • Osteotomy Arm

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • 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.

    Kezelés: Custom-made 'cutting block'

  • 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.

    Kezelés: Custom-made 'cutting block'

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Patient Matched Osteotomy to Correct Angular Deformities in Knee Arthrosis
A regiszteradat frissítve
2019. március 13.