ArthroplastyoneKNEENCT07682909
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
An observational study of Arthroplasty and Arthroplasty Replacement, Knee, run by Aesculap AG.
Trial summary
Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee
- What is being tested?
- oneKNEE®
- Type of treatment
- Medical device
- How many people
- 1,020 participants
- Where
- No sites listed yet
- Study dates
- Apr 2027to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving a total knee prosthesis
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: oneKNEE - Prospective, Non-interventional, Multicenter Post-Market Clinical Follow-Up Study
Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.
Read the 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.
- Conditions
- Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes
- Being tested
- oneKNEE®
- Keywords
- Total Knee Arthroplasty, Safety and Clinical Performance, oneKnee, Integrated platform of knee implants and instruments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oneKNEE®Device
Total knee prostheses
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years after implantation
Secondary outcomes (14)
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.
Measured: V4=3 months post OP, V5= 1year p.OP, V6= 2years p.OP, V7= 5years 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
Measured: 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
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.
Measured: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP
Anterior knee pain
Anterior knee pain is used to evaluate the performance of the implantation and the implant itself. Rating is classified according to the description of Waters and Bentley in four dimensions: 0 (no pain), I (Mild pain that does not intrude on daily activities), II (Moderate pain that is a nuisance; patient not considering further surgery), III (Severe pain; Patient considering further surgery). The scoring is according to Feller et al. 0, 5, 10 and 15 points, respectively.
(Feller et al., J Bone Joint Surg Am. 2003 Feb;85(2):212-7).
Measured: 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
Range of Motion (ROM)
Measured: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 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.
Measured: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 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°.
Measured: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 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)
Measured: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 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.
Measured: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP
Adverse events
Serious and non-serious adverse events (SAE/AE)
Measured: until end of study, up to 5 years.
Device deficiencies assessed by Adverse Events
In any case of Adverse Events marked as "related to the product/device"
Measured: until end of study, up to 5 years
Intraoperative complications
Measured: day of surgery
Survival of implant components
Measured: From V3=Discharge to V7= 5 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.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startApr 2027 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Postler, PD Dr. med, Principal investigator, Städt. Klinikum Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682909
- Sponsor's protocol ID
- AAG-O-H-25103
- Acronym
- oneKNEE
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- oneKNEE - Prospective, Non-interventional, Multicenter Post-Market Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT07682909
- Acronym / sponsor ID
- oneKNEE / AAG-O-H-25103
- Conditions
- Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes
- Keywords
- Total Knee Arthroplasty, Safety and Clinical Performance, oneKnee, Integrated platform of knee implants and instruments
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2027 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving a total knee prosthesis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Contraindications acc. to the Instructions for Use (IFU)
- Patient age < 18 years
- Known pregnancy
- BMI > 40
- Secondary gonarthrosis (e.g. rheumatoid arthritis, post-traumatic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oneKNEE®Total knee prostheses | Device | – |
Primary outcome
Safety of the implant
Time frame: 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.
Clinical Performance in terms of clinical outcome of oneKNEE®
Time frame: 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.
14 secondary outcomes
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
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,
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
Anterior knee pain
Time frame: 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
Time frame: V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 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
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
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
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
Adverse events
Time frame: until end of study, up to 5 years.
Device deficiencies assessed by Adverse Events
Time frame: until end of study, up to 5 years
Intraoperative complications
Time frame: day of surgery
Survival of implant components
Time frame: From V3=Discharge to V7= 5 years post OP
Optional: OrthoPilot® Data
Time frame: Day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Postler, PD Dr. med principal investigator
Städt. Klinikum Dresden
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty and Arthroplasty Replacement, Knee, run by Aesculap AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heike Oberascher (+49 7461 95 ext. 0, studies@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the implant (time frame: 2 years after implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.