The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance. Patient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.
Study Type
OBSERVATIONAL
Enrollment
120
The OrthoPilot® Software Pheno4u TKA Level 1 is an application software for computer aided navigation of surgical instruments and serves (in combination with compatible hardware and compatible navigated instruments) as an optional aid for the surgeon during the preparation of the implant site for a compatible knee endoprosthesis.
Šumperk Hospital Inc.
Šumperk, Czechia
NOT_YET_RECRUITINGKlinikum Konstanz GmbH
Konstanz, Baden-Wurttemberg, Germany
NOT_YET_RECRUITINGPark-Klinik Weißensee
Berlin, Germany
RECRUITINGComparison of the surgical accuracy between the new OrthoPilot Software and the previous OrthoPilot Software
The primary variable delta (aHKA), is defined as the difference in the arithmetic hip-knee-angle (aHKA) between the 3 months postoperative and the intraoperatively planned value. The aHKA is calculated as the difference of the mechanical medial proximal tibial angle (MPTA) and the mechanical lateral distal femoral angle (LDFA), both measured in degrees.
Time frame: 3 months post OP
Implant survival
Secondary interventions at the index knee
Time frame: ongoing, up to 2 years follow-up
Oxford Knee Score (OKS)
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: Preoperative,3 months-, 12 months and 2 years post operative
Forgotten Joint Score (FJS)
The FJS-12 contains 12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48\*100). Lower scores indicate less awareness of the operated knee during daily activities. The range of the final score is from 0 to 100 (where 0 is worst and 100 means best score)
Time frame: Preoperative,3 months-, 12 months and 2 years post operative
Quality of Life (EQ-5D-5L)
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Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Quality of life of the patients will be analyzed using the 5-dimensions 5-level measure of the EuroQol Group (EQ-5D-5L), which is a simple and generic measure for clinical and economic assessment. The questionnaire covers five different dimensions (mobility, self-care, usual activities,pain/discomfort, anxiety/depression) rated in 5 levels (from "the worst health you can imagine" to "the best health you can imagine"). The questionnaire is filled by the patients themselves.
Time frame: Preoperative, Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months
NET Promotor Score (NPS)
The Net Promoter Score (NPS) was developed for measuring satisfaction in economic research. Colloquially, it is referred to as the "friends and family test". In the healthcare sector, the NPS is used as an overarching measure of patient satisfaction. The NPS metric evaluates the likelihood that a patient will recommend the received healthcare service to others. The NPS is assessed using a scale from 1 to 10. A rating between 9 and 10 is classified as a promoter. A rating between 7 and 8 is considered neutral, and a rating between 0 and 6 is deemed a detractor. The overall score is simply calculated by subtracting the percentage of detractors from the percentage of promoters. Scores range from -100 (everyone is a detractor) to +100 (everyone is a promoter). In the industry, a positive score is viewed favorably, and scores above 50 are considered indicative of strong performance.
Time frame: Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months
Anterior knee pain
Anterior knee pain will be used to evaluate the performance of the implantation and the implant itself. Rating Description Points: 0 = No pain (0 Points) I = Mild pain that does not intrude on daily activities (5 Points) II= Moderate pain that is a nuisance; patient not considering further surgery (10 Points) III= Severe pain; patient considering further surgery (15 Points)
Time frame: Preoperative,3 months-, 12 months and 2 years post operative
Radiological results
Routinely performed radiographic images are used to evaluate the status of the affected knee, preoperatively, and the status of the implant components, postoperatively. Analysis of parameters will be defined in the radiographic protocol, where precise definition of the implant alignment parameter of the tibial and femoral component by measurement of the LDFA (laterale distale Femurankle) and MPTA (medial proximal Tibiaankle) is given. Both ankles have the same unit and are measured in degrees.
Time frame: Preoperative, Discharge, 1 year post op
All (Serious) Adverse Events
During the course of the study, any upcoming intra- or postoperative (serious) adverse will be documented. The total number of AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed to assess the safety of the investigational product.
Time frame: 2 years