oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study (oneKNEE)

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.

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.

Intraoperative complications

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.

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.

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

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.

Knee functional outcome

Range of Motion (ROM)

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.

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°.

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)

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.

Adverse events

Serious and non-serious adverse events (SAE/AE)

Device deficiencies assessed by Adverse Events

In any case of Adverse Events marked as "related to the product/device"

Survival of implant components

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).