The Effect of Three Prosthesis Designs in Total Knee Arthroplasty
19. april 2017 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
216
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yasser Rehman, MD
- Telefonnummer: +4798477583
- E-post: yare@lds.no
Studiesteder
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Haugesund, Norge, 5528
- Har ikke rekruttert ennå
- Haugesund Rheumatism Hospital
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Ta kontakt med:
- Øystein Gøthesen, Md, PhD
- Telefonnummer: 988 08162
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Oslo, Norge, 0446
- Rekruttering
- Lovisenberg Diaconal Hospital
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Ta kontakt med:
- Arild Aamodt, MD, PhD
- E-post: aara@lds.no
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Hovedetterforsker:
- Yasser Rehman, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Knee arthroplasty, Cruciate retaining
Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert.
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Legion total knee arthroplasty implant component, Smith & Nephew, Cruciate Retaining design
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Aktiv komparator: Knee arthroplasty, Anterior stabilized
Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert.
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Legion total knee arthroplasty implant component, Smith & Nephew, Anterior Stabilized design
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Aktiv komparator: Knee arthroplasty, Posterior stabilized
Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design.
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Legion total knee arthroplasty implant component, Smith & Nephew, Posterior Stabilized design
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Knee injury and osteoarthritis outcome score (KOOS)
Tidsramme: Pre-operative, 1, 2 and 5 years
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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.
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Pre-operative, 1, 2 and 5 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Oxford knee score (OKS)
Tidsramme: Pre-operative, 1, 2 and 5 years
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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.
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Pre-operative, 1, 2 and 5 years
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EQ-5D-5L
Tidsramme: Pre-operative, 1, 2 and 5 years
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EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life
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Pre-operative, 1, 2 and 5 years
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Range of motion (ROM)
Tidsramme: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
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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
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Pre-operative, 6 weeks, 3, 12, 24 and 60 months
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Kinematic radiostereometric analysis (RSA)
Tidsramme: After 12 months
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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.
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After 12 months
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Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs
Tidsramme: Pre-operative, 3, 12, 24 and 60 months
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Radiographs obtained for assessment of fixation of the prosthesis and the alignment.
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Pre-operative, 3, 12, 24 and 60 months
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Brief Pain Inventory
Tidsramme: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
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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.
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Pre-operative, 6 weeks, 3, 12, 24 and 60 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Arild Aamodt, MD, PhD, Lovisenberg Diaconal Hospital, Oslo, Norway
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2017
Primær fullføring (Forventet)
31. desember 2023
Studiet fullført (Forventet)
31. desember 2023
Datoer for studieregistrering
Først innsendt
16. februar 2017
Først innsendt som oppfylte QC-kriteriene
16. februar 2017
Først lagt ut (Faktiske)
23. februar 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. april 2017
Sist bekreftet
1. februar 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LovisenbergOrto
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