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

NCT07682909 | Not Yet Recruiting

• 1 other identifier: AAG-O-H-25103
• Study Type: observational
• Target: 1,020
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Arthroplasty Replacement, Knee; Prosthetic Joint Infections of Knee; TKA Outcomes; Arthroplasty

Keywords

Total Knee Arthroplasty; Safety and Clinical Performance; oneKnee; Integrated 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 (13)

• 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, V8= 7years p.OP, V9=10 years p.OP, V10=15 y. 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, V8= 7 years post OP, V9= 10 years post OP, V10= 15 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, V8= 7 years post OP, V9= 10 years post OP, V10= 15 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, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP

• Knee alignment, measurement of LDFA: 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

Interventions

oneKNEE® DEVICE

Total knee prostheses

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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

Sponsors & Collaborators

• Aesculap AG: lead

Study Officials

• Anne Postler, PD Dr. med

  Städt. Klinikum Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heike Oberascher

CONTACT

+49 7461 95; studies@aesculap.de

Stefan Maenz, Dr.

CONTACT

+49 7461 95; studies@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): December 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2042
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share