Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAesculap AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients between 18 and 80 years of age having indication for a fixed-bearing total knee endoprosthesis, without retropatellar arthrosis requiring patella resurfacing
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Navigated Total Knee Arthroplasty
Procedure/SurgeryThe 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: pheno4u TKA Level 11 intervention
Trial outcomes
Primary outcomes
1
Comparison 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 OPSecondary outcomes
1
Implant survival
Secondary interventions at the index knee
Time frame
ongoing, up to 2 years follow-up2
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 operative3
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 operative4
Quality of Life (EQ-5D-5L)
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aesculap AG
Lead sponsor
Raylytic GmbH
Collaborator
Source ClinicalTrials.gov