An observational study in Arthroplasty, Arthroplasty Replacement, Knee and Prosthetic Joint Infections of Knee, sponsored by Aesculap AG. Not yet recruiting. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Aesculap AG (part of B. Braun) · Observational
Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.
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.
Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients receiving a total knee prosthesis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Total knee prostheses
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.
Time frame: 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.
Time frame: 2 years after implantation
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.
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
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
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
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.
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
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).
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
Range of Motion (ROM)
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
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.
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
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°.
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
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)
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
"Image biopsy lab" is a Digital AI platform that supports physicians and healthcare professionals in transforming medical imaging data into diagnostic findings.
Time frame: 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)
Time frame: 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"
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
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.
Time frame: Day of surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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