NCT07682909

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,020

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Apr 2027

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

June 18, 2026

Last Update Submit

August 12, 2026

Conditions

Arthroplasty Replacement, KneeProsthetic Joint Infections of KneeTKA OutcomesArthroplasty

Keywords

Total Knee ArthroplastySafety and Clinical PerformanceoneKneeIntegrated platform of knee implants and instruments

Outcome Measures

Primary Outcomes (2)

  • Safety of the implant

    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®

    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

Secondary Outcomes (14)

  • Clinical Outcome by evaluating the Oxford Knee Score

    V4=3 months post OP, V5= 1year p.OP, V6= 2years p.OP, V7= 5years p.OP

  • Evaluation of Changes in Quality of Life

    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,

  • Evaluation of Patient Satisfaction by using PROMS: FJS

    V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP

  • Anterior knee pain

    V1= preoperatively, V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP,

  • Knee functional outcome

    V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP

  • +9 more secondary outcomes

Interventions

oneKNEE®DEVICE

Total knee prostheses

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving a total knee prosthesis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Anne Postler, PD Dr. med

    Städt. Klinikum Dresden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heike Oberascher

CONTACT

+49 7461 95studies@aesculap.de

Stefan Maenz, Dr.

CONTACT

+49 7461 95studies@aesculap.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2026

First Posted

July 6, 2026

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

December 1, 2031

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share