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The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

19. april 2017 opdateret af: Lovisenberg Diakonale Hospital

The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial

The purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Total knee arthroplasty (TKA) is a cost beneficial surgery shown to improve pain, function and quality of life in patients with osteoarthritis. In 2015, 6093 patients received primary TKA in Norway. Despite the procedure´s general success, 20% of patients report persistent postoperative pain and/or dissatisfaction with the surgical outcome. Efforts to further improve the procedure have raised considerable debate regarding the role and management of the posterior cruciate ligament (PCL). Prostheses for TKA have evolved into designs that either preserve or sacrifice the PCL. In patients with a functional PCL, the decision of which design is selected depends largely on the favor and training of the surgeon. To further improve TKA patient outcomes, a better understanding of the role of these differing PCL treatments is needed. Thus, the aim of this study is to determine whether patients' perceived outcome, implant stability and clinical outcome differ between 3 TKA implant designs (2 PCL-sacrificing and 1 PCL-retaining). We will conduct a 3-arm randomized controlled prospective trial with 5-year follow-up. This study will have impact on clinical practice by addressing the lack of evidence supporting use of these different types of implants.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

216

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Yasser Rehman, MD
  • Telefonnummer: +4798477583
  • E-mail: yare@lds.no

Studiesteder

  • Norge
      • Haugesund, Norge, 5528
        • Ikke rekrutterer endnu
        • Haugesund Rheumatism Hospital
        • Kontakt:
          • Øystein Gøthesen, Md, PhD
          • Telefonnummer: 988 08162
      • Oslo, Norge, 0446
        • Rekruttering
        • Lovisenberg Diaconal Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Yasser Rehman, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Primary osteoarthritis
  • Non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (HKA) radiographs
  • Intact PCL (assessed preoperatively and verified during surgery)
  • Age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic RSA)
  • Body mass index ≤ 35 kg/m2
  • ASA (American Society of Anaesthesiologists) score I or II
  • Only patients with KOOS scores above 80 on the Symptoms, ADL (Activities of Daily Living) and Pain subscales will be included in the kinematic analysis

Exclusion Criteria:

  • Prior ACL (anterior cruciate ligament) surgery
  • Impaired collateral ligaments
  • Secondary osteoarthritis of the knee
  • Previous osteotomy
  • Rheumatic disease
  • Flexion less than 90 degrees
  • Flexion contracture over 10 degrees
  • Peripheral neuropathy
  • Malignancy
  • Patients who do not speak Norwegian

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Knee arthroplasty, Cruciate retaining
Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert.
Procedure: Knee arthroplasty, Cruciate retaining
Legion total knee arthroplasty implant component, Smith & Nephew, Cruciate Retaining design
Aktiv komparator: Knee arthroplasty, Anterior stabilized
Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert.
Procedure: Knee arthroplasty, Anterior stabilized
Legion total knee arthroplasty implant component, Smith & Nephew, Anterior Stabilized design
Aktiv komparator: Knee arthroplasty, Posterior stabilized
Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design.
Procedure: Knee arthroplasty, Posterior stabilized
Legion total knee arthroplasty implant component, Smith & Nephew, Posterior Stabilized design

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knee injury and osteoarthritis outcome score (KOOS)
Tidsramme: Pre-operative, 1, 2 and 5 years
KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire.
Pre-operative, 1, 2 and 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oxford knee score (OKS)
Tidsramme: Pre-operative, 1, 2 and 5 years
OKS is a brief patient-completed questionnaire for patients undergoing total knee arthroplasty. It reflects the patient's assessment of their knee-related health status and benefits of treatment.
Pre-operative, 1, 2 and 5 years
EQ-5D-5L
Tidsramme: Pre-operative, 1, 2 and 5 years
EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life
Pre-operative, 1, 2 and 5 years
Range of motion (ROM)
Tidsramme: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
ROM will be measured by extension and flexion with a goniometer preoperatively at baseline and at each follow-up visit (6 weeks, 3 months, 12 months, 24 months and 60 months
Pre-operative, 6 weeks, 3, 12, 24 and 60 months
Kinematic radiostereometric analysis (RSA)
Tidsramme: After 12 months
Knee motion while walking up and down stairs, and during squatting and kneeling activities will be recorded using video fluoroscopy (dynamic RSA) at 12 months.
After 12 months
Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs
Tidsramme: Pre-operative, 3, 12, 24 and 60 months
Radiographs obtained for assessment of fixation of the prosthesis and the alignment.
Pre-operative, 3, 12, 24 and 60 months
Brief Pain Inventory
Tidsramme: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
We will use three single items to measure worst pain intensity, average pain intensity, and pain interference with walking. Patients rate their pain intensity and pain interference with walking on an 11-point numeric rating scale from 0-10, where 0=no pain/no interference and 10=worst imaginable pain/complete interference.
Pre-operative, 6 weeks, 3, 12, 24 and 60 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Lovisenberg Diakonale Hospital

Samarbejdspartnere

Haugesund Rheumatism Hospital

Efterforskere

  • Studieleder: Arild Aamodt, MD, PhD, Lovisenberg Diaconal Hospital, Oslo, Norway

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2017

Primær færdiggørelse (Forventet)

31. december 2023

Studieafslutning (Forventet)

31. december 2023

Datoer for studieregistrering

Først indsendt

16. februar 2017

Først indsendt, der opfyldte QC-kriterier

16. februar 2017

Først opslået (Faktiske)

23. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. april 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LovisenbergOrto

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Gonarthrose; Primær

Kliniske forsøg med Knee arthroplasty, Cruciate retaining

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