Orthopilot Elite Post-Market Clinical Follow-Up
Prospective, Multicenter, Observational, Comparative Clinical Trial on the Equivalence of Two Different OrthoPilot® Navigation System Generations Applied for Computer-assisted Total Knee Arthroplasty
1 other identifier
observational
217
1 country
3
Brief Summary
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2019
CompletedFirst Posted
Study publicly available on registry
January 25, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2022
CompletedJanuary 17, 2023
January 1, 2023
3 years
January 23, 2019
January 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Lower Limb Alignment inside the range of 0±3°
A postoperative lower limb alignment of the knee prosthesis in reference to the mechanical leg axis (3, 18) outside the range of ± 3° is defined as the outlier. The outlier rates will be used as the efficacy criterion for groups comparison
three months postoperatively
Secondary Outcomes (7)
Lower limb alignment of the knee prosthesis in reference to the mechanical leg axis
3 months postoperatively
Improvement of Knee Society Score (KSS)
preoperatively and three months postoperatively
Improvement of Oxford Knee Score (OKS)
preoperatively and three months postoperatively
Improvement of Quality of Life (EQ-5D-5L)
preoperatively and three months postoperatively
Learning Curve
Intraoperatively
- +2 more secondary outcomes
Study Arms (2)
A Standard
Computer assisted primary total knee replacement with OrthoPilot FS 101 navigation system and Software 5.1
B Elite
Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
Interventions
Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1
Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0
Eligibility Criteria
adult patients
You may qualify if:
- Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant
- Dated and signed informed consent
You may not qualify if:
- Pregnancy
- Patients \< 18 years
- Patients unable to participate at the follow-up examination (physically, mentally)
- Previous joint replacement at the indexed knee
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
Study Sites (3)
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Uniklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Schönkliniken Klinikum Eilbek
Hamburg, 22081, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2019
First Posted
January 25, 2019
Study Start
July 1, 2019
Primary Completion
June 30, 2022
Study Completion
October 29, 2022
Last Updated
January 17, 2023
Record last verified: 2023-01