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Prospective, Non-interventional, Multicenter Post-Market Clinical Follow-Up Study (oneKNEE)

1. juli 2026 opdateret af: Aesculap AG

oneKNEE - Prospective, Non-interventional, Multicenter Post-Market Clinical Follow-Up Studies

Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Safety and Clinical Performance will be observed:

Safety: All adverse device effects: serious and non-serious adverse events with relation to either the product or the surgical procedure.

Clinical Performance: Difference in Oxford Knee Score (OKS) 2 years after implantation compared to preoperative state.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1020

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients receiving a total knee prosthesis

Beskrivelse

Inclusion Criteria:

  • Patient age ≤ 80 years
  • Indication for a total knee replacement with one of the variants
  • Written informed consent
  • Willingness and mental ability to participate at the long-term follow-up examinations

Exclusion Criteria:

  • Contraindications acc. to the Instructions for Use (IFU)
  • Patient age < 18 years
  • Known pregnancy
  • BMI > 40
  • Secondary gonarthrosis (e.g. rheumatoid arthritis, post-traumatic)
  • Patients classified as high risk (ASA class >3)
  • Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
  • Preoperative: aHKA > 190° or aHKA < 170°
  • Preoperative: aHKA > 190° or aHKA < 170°[KB1.1][HO1.2][KB1.3][HO1.4]
  • Patients held in a custodial setting und - Patients in a relationship of dependence on the sponsor, the clinic or the investigator

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety of the implant
Tidsramme: 2 years after implantation
Safety in terms of clinical outcome of oneKNEE® All adverse device effects: serious and non-serious adverse events with relation to either the product or the surgical procedure.
2 years after implantation
Clinical Performance in terms of clinical outcome of oneKNEE®
Tidsramme: 2 years after implantation

Clinical Performance in terms of clinical outcome of oneKNEE®. Difference in Oxford Knee Score (OKS) 2 years after implantation compared to preoperative state.

The Oxford Knee Score (OKS) is a validated joint-specific patient-reported outcome measure that is commonly employed to assess the outcome of TKA. It is a 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing TKA. It is short, reproducible, valid and sensitive to clinically important changes over time. OKS ranges from 0 to 48 with 48 being the best outcome.
2 years after implantation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Outcome by evaluating the Oxford Knee Score
Tidsramme: V4=3 months post OP, V5= 1year p.OP, V6= 2years p.OP, V7= 5years p.OP, V8= 7years p.OP, V9=10 years p.OP, V10=15 y. p.OP
The Oxford Knee Score, OKS is a validated joint-specific patient-reported outcome measure that is commonly employed to assess the outcome of TKA. It is a 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing TKA. It is short, reproducible, valid and sensitive to clinically important changes over time. OKS ranges from 0 to 48 with 48 being the best outcome.
V4=3 months post OP, V5= 1year p.OP, V6= 2years p.OP, V7= 5years p.OP, V8= 7years p.OP, V9=10 years p.OP, V10=15 y. p.OP
Evaluation of Changes in Quality of Life
Tidsramme: V1= pre OP, V3= Discharge, V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP

The EQ-5D-5L is a standardized instrument used to measure health outcomes. Developed by the EuroQol Group (EQ), it assesses five dimensions (5D) of health:

Mobility Self-care Usual activities Pain/discomfort Anxiety/depression Each dimension has five levels (5L) of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems
V1= pre OP, V3= Discharge, V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
Evaluation of Patient Satisfaction by using PROMS: FJS
Tidsramme: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP

Forgotten Joint Score (FJS) : A joint-specific questionnaire with the aim to measure PRO of joint disorders . FJS is designed to measure the ability of the patient to "forget" about their problematic joint after treatment. Scale:

  • 12 questions (How often are you aware of your affected knee joint in everyday life?)
  • 5-point response scale (0-4)
  • responses are then summed and divided by the number of completed items
  • mean value is then multiplied by 25 to obtain the total score of 0-100. A higher score indicates that the patient is less aware of their joint, suggesting better surgical outcomes and higher levels of patient satisfaction.
V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
Knee functional outcome
Tidsramme: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
Range of Motion (ROM)
V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
Knee alignment, measurement of LDFA: Lateral distal femoral angle
Tidsramme: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
LDFA: Lateral distal femoral angle. The angle between the mechanical axis of the femur and the knee joint line. Normal values typically range between 85° and 90° Medial proximal tibial angle (MPTA) and lateral distal femoral angle.
V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
Knee alignment, measurement of MPTA: Medial proximal tibial angle
Tidsramme: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
MPTA: Medial proximal tibial angle. The angle between the mechanical axis of the tibia and the knee joint line. Normal values also typically average around 87° ± 3°.
V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
Knee alignment, measurement of HKA: Hip Knee Angle
Tidsramme: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
HKA: (Hip Knee Angle). The mechanical angle between the center of the femoral head, the center of the knee, and the center of the ankle. It represents the overall lower limb alignment (e.g., neutral, varus, or valgus)
V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
Radiologically relevant findings by using AI
Tidsramme: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
"Image biopsy lab" is a Digital AI platform that supports physicians and healthcare professionals in transforming medical imaging data into diagnostic findings.
V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP
Adverse events
Tidsramme: 15 years
Serious and non-serious adverse events (SAE/AE)
15 years
Device deficiencies assessed by Adverse Events
Tidsramme: 15 years
In any case of Adverse Events marked as "related to the product/device"
15 years
Intraoperative complications
Tidsramme: day of surgery
day of surgery
Survival of implant components
Tidsramme: From V3=Discharge to V10 = 15 years post OP
From V3=Discharge to V10 = 15 years post OP
Optional: OrthoPilot® Data
Tidsramme: Day of surgery
During surgery all data measured and stored by OrthoPilot® the computer assistant (e.g. time needed for the surgery, alignment of all implant components) will be evaluated.
Day of surgery

Samarbejdspartnere og efterforskere

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

Sponsor

Aesculap AG

Efterforskere

  • Ledende efterforsker: Anne Postler, PD Dr. med, Städt. Klinikum Dresden

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 (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. december 2042

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • AAG-O-H-25103

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Artroplastik

Kliniske forsøg med oneKNEE®

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Trinidad & Tobago

Betingelser

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Narkotikainterventioner

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Placeringer

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