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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oneKNEE® | Device | Total knee prostheses |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving a total knee prosthesis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heike Oberascher | Contact | +49 7461 95 | 0 | studies@aesculap.de |
| Stefan Maenz, Dr. | Contact | +49 7461 95 | 0 | studies@aesculap.de |
| Name | Affiliation | Role |
|---|---|---|
| Anne Postler, PD Dr. med | Städt. Klinikum Dresden | Principal Investigator |
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| 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:
| 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 |