- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02118272
Clinical Study Evaluating the Outcomes of a New Knee System With a Physiological Rollback Mechanism (K-06)
1. april 2021 opdateret af: Limacorporate S.p.a
A Multicentre, Prospective Clinical Study Evaluating the Outcomes of a New Knee System With a Physiological Rollback Mechanism
The aim of this study is to assess the clinical, radiographic and patient-reported outcome measures (PROMs) after total knee replacement with Physica KR, define the survivorship of the implants and identify possible risk factors that may lead to failure.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
156
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Dorset
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Bournemouth, Dorset, Det Forenede Kongerige, BH7 7DW
- The Royal Bournemouth Hospital, NHS Foundation Trust
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Dorchester, Dorset, Det Forenede Kongerige, DT1 2JY
- Dorset County Hospital NHS Foundation Trust
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Florence, Italien, 50134
- Azienda Ospedaliero-Universitaria Careggi
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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
22 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male and females
- Age 22-80 years
- Any race
- Ambulatory patients
- Patients who have a medical condition with over 5 years of life expectancy
- Patients requiring knee prosthesis, suitable for the use of Physica KR
- Patients with painful primary knee osteoarthritis
- Patients with painful secondary knee osteoarthritis
- Patients who are suffering from inflammatory arthritis (e.g. rheumatoid arthritis)
- Patients who have undamaged and functional collateral and posterior cruciate ligaments
- Patients with a flexion greater than or equal to 90° on the affected side
- Patients with a fixed flexion contracture less than 10°
- Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits
- Patients who have signed the Ethics Committee approved study-specific Informed Consent Form prior to the surgery
Exclusion Criteria:
- Obese patients with BMI above 35 kg/m2 (severe obesity)
- Previous partial knee replacement (unilateral, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or femoral osteotomy in the affected knee
- Primary Total Knee Replacement (TKR) in the affected knee
- Varus or Valgus deformity greater than 20°
- Patients with a fixed flexion contracture greater than 10°
- Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS< 70 points
- Patients with symptomatic OA of the hips, spine, ankles, if it can interfere with the evaluation of the target knee
- Patients with active or any suspected infection (on the affected knee or systemic)
- Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance
- Patients with known or suspicious metal hypersensitivity
- Recurrent medical history of severe allergic or immune-mediated reactions
- Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
- Current treatment or treatment within the previous 2 years before the screening visit for malignant and life-threatening non-malignant disorders
- Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation
- Any intercurrent chronic disease or condition that may interfere with the completion of the 5-year follow-up, such as liver disease, severe coronary disease, alcohol or drug abuse, disordered mental state, or other clinically significant condition
- Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
- Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
- Patients with systemic or metabolic disorders leading to progressive bone deterioration
- Patients who have a medical condition with less 5 years of life expectancy
- Previous organ transplant surgery
- Any psychiatric illness that would prevent comprehension of the details and nature of the study
- Participation in any experimental drug/device study within the 6 months prior to the screening visit
- Female patients who are pregnant, nursing, or planning a pregnancy
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: Physica KR
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Knee Society Clinical Rating System (KSS)
Tidsramme: From baseline to 5 year follow up
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From baseline to 5 year follow up
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Knee injury and Osteoarthritis Outcome Score (KOOS)
Tidsramme: From baseline to 5 year follow-up
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From baseline to 5 year follow-up
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Oxford Knee Score (OKS)
Tidsramme: From baseline to 5 year follow-up
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From baseline to 5 year follow-up
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Satisfaction Visual Analogue Scale (VAS)
Tidsramme: From baseline to 5 year follow-up
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From baseline to 5 year follow-up
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Survival rate of the implant
Tidsramme: at 3 and 5 year follow-up
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at 3 and 5 year follow-up
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Incidence of AE/SAE, ADE/SADE
Tidsramme: From baseline to 5 year follow-up
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From baseline to 5 year follow-up
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Forgotten Joint score (FJS)
Tidsramme: From baseline to 5 year follow-up
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From baseline to 5 year follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. maj 2014
Primær færdiggørelse (Forventet)
1. november 2021
Studieafslutning (Forventet)
1. november 2021
Datoer for studieregistrering
Først indsendt
11. april 2014
Først indsendt, der opfyldte QC-kriterier
16. april 2014
Først opslået (Skøn)
21. april 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- K-06 Physica KR
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Primary Total Knee Replacement
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