Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes
Conditions
Keywords
Total Knee Arthroplasty, Safety and Clinical Performance, oneKnee, Integrated platform of knee implants and instruments
Brief summary
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.
Interventions
DEVICEoneKNEE®
Total knee prostheses
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the implant | 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® | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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, | 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 |
| 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 | 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. |
| Anterior knee pain | V1= preoperatively, V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, | 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). |
| Knee functional outcome | V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP | Range of Motion (ROM) |
| 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 | 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. |
| Knee alignment, measurement of MPTA: Medial proximal tibial angle | V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP | 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°. |
| Knee alignment, measurement of HKA: Hip Knee Angle | V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP | 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) |
| Radiologically relevant findings by using AI | V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP | "Image biopsy lab" is a Digital AI platform that supports physicians and healthcare professionals in transforming medical imaging data into diagnostic findings. |
| Adverse events | until end of study, up to 5 years. | Serious and non-serious adverse events (SAE/AE) |
| Device deficiencies assessed by Adverse Events | until end of study, up to 5 years | In any case of Adverse Events marked as "related to the product/device" |
| Intraoperative complications | day of surgery | — |
| Survival of implant components | From V3=Discharge to V7= 5 years post OP | — |
| Optional: OrthoPilot® Data | Day of surgery | 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. |
Contacts
CONTACTHeike Oberascher
CONTACTStefan Maenz, Dr.
PRINCIPAL_INVESTIGATORAnne Postler, PD Dr. med
Städt. Klinikum Dresden
Outcome results
None listed