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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthroplasty; Arthroplasty Replacement, Knee; Prosthetic Joint Infections of Knee; TKA Outcomes
• Intervention / Treatment: Device: oneKNEE®

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.

• Study Type: Observational
• Enrollment (Estimated): 1020

Contacts and Locations

• Study Contact: Name: Heike Oberascher; Phone Number: +49 7461 95; Email: studies@aesculap.de
• Study Contact Backup: Name: Stefan Maenz, Dr.; Phone Number: +49 7461 95; Email: studies@aesculap.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving a total knee prosthesis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome by evaluating the Oxford Knee Score	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	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	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	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	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	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	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	"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	Serious and non-serious adverse events (SAE/AE)	15 years
Device deficiencies assessed by Adverse Events	In any case of Adverse Events marked as "related to the product/device"	15 years
Intraoperative complications		day of surgery
Survival of implant components		From V3=Discharge to V10 = 15 years post OP
Optional: OrthoPilot® Data	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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Anne Postler, PD Dr. med, Städt. Klinikum Dresden

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2042

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Safety and Clinical Performance; oneKnee; Integrated platform of knee implants and instruments
• Other Study ID Numbers: AAG-O-H-25103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No