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Not yet recruiting NCT07682909

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

— Observational Arthroplasty Arthroplasty Replacement, Knee Prosthetic Joint Infections of Knee TKA Outcomes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: oneKNEE®.
Who it may be relevant to
Registry conditions: Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Device oneKNEE®
    Total knee prostheses

Primary outcome measures

  • Safety of the implant [Time frame: 2 years after implantation]
  • Clinical Performance in terms of clinical outcome of oneKNEE® [Time frame: 2 years after implantation]
Secondary outcome measures (12)
  • Clinical Outcome by evaluating the Oxford Knee Score [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 15 years]
  • Device deficiencies assessed by Adverse Events [Time frame: 15 years]
  • Intraoperative complications [Time frame: day of surgery]
  • Survival of implant components [Time frame: From V3=Discharge to V10 = 15 years post OP]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07682909 · AAG-O-H-25103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗