Joint Diseases, Osteoarthritis, Knee, Posttraumatic Arthropathy, Rheumatoid Arthritis of Knee
Conditions
Keywords
Navigation, Total Knee Arthroplasty, OrthoPilot
Brief summary
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.
Interventions
PROCEDURENavigated Total Knee Arthroplasty
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.
Sponsors
Raylytic GmbH
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Indication for a TKA with the OrthoPilot® Navigation System with a Aesculap total knee endo-prosthesis * Written signed informed consent of patient * Willingness and mental ability to participate at the long-term follow-up examinations
Exclusion criteria
* Pregnancy * Patients \< 18 years or \> 80 years * Patients unable to participate at the follow-up examination (physically, mentally) * Previous joint replacement at the index knee * ASA classification \> 3 ( ASA I: A healthy patient without systemic diseases. ASA II: A patient with a mild systemic disease that is well controlled (e.g., well-controlled diabetes or hypertension). ASA III: A patient with a severe systemic disease that causes functional limitations (e.g., poorly controlled diabetes, COPD). ASA IV: A patient with a life-threatening systemic disease (e.g., severe heart failure, sepsis). ASA V: A dying patient who is not expected to survive without the operation. ASA VI: A deceased patient whose organs are being removed for donation.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the surgical accuracy between the new OrthoPilot Software and the previous OrthoPilot Software | 3 months post OP | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score (OKS) | Preoperative,3 months-, 12 months and 2 years post operative | 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. |
| Forgotten Joint Score (FJS) | Preoperative,3 months-, 12 months and 2 years post operative | 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) |
| Quality of Life (EQ-5D-5L) | Preoperative, Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months | 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. |
| Implant survival | ongoing, up to 2 years follow-up | Secondary interventions at the index knee |
| Anterior knee pain | Preoperative,3 months-, 12 months and 2 years post operative | 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) |
| Radiological results | Preoperative, Discharge, 1 year post op | 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. |
| All (Serious) Adverse Events | 2 years | 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. |
| NET Promotor Score (NPS) | Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months | 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. |
Countries
Czechia, Germany
Contacts
Primary ContactHeike Oberascher
Backup ContactStefan Maenz, Dr.
Outcome results
None listed