Rheumatoid Arthritis Clinical Trial
Official title:
Prospective, Multicenter, Observational, Comparative Clinical Trial on the Equivalence of Two Different OrthoPilot® Navigation System Generations Applied for Computer-assisted Total Knee Arthroplasty
NCT number | NCT03817632 |
Other study ID # | AAG-O-H-1708 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | October 29, 2022 |
Verified date | January 2023 |
Source | Aesculap AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty
Status | Completed |
Enrollment | 217 |
Est. completion date | October 29, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion: Inclusion Criteria: - Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant - Dated and signed informed consent Exclusion: Exclusion Criteria - Pregnancy - Patients < 18 years - Patients unable to participate at the follow-up examination (physically, mentally) - Previous joint replacement at the indexed knee |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Carl Gustav Carus | Dresden | |
Germany | Uniklinikum Freiburg | Freiburg | |
Germany | Schönkliniken Klinikum Eilbek | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Aesculap AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Lower limb alignment of the knee prosthesis in reference to the mechanical leg axis | The outcome and function of a prosthesis is influenced by the postoperative alignment of the leg and the orientation in reference to the axis. Incorrect positioning can lead to an increased implant wear and functional limitations (23, 24). The aim of a postoperative alignment within 3° varus to 3° valgus will be assessed using long leg x-rays 3-4 months postoperatively. | 3 months postoperatively | |
Secondary | Improvement of Knee Society Score (KSS) | The KSS score is composed of two subgroups and has a maximum score of 200. | preoperatively and three months postoperatively | |
Secondary | Improvement of Oxford Knee Score (OKS) | A patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total knee replacement (TKR) arthroplasty. Oxford Knee Score has a maximum of 48 points indicating satisfactory knee function | preoperatively and three months postoperatively | |
Secondary | Improvement of Quality of Life (EQ-5D-5L) | The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. |
preoperatively and three months postoperatively | |
Secondary | Learning Curve | The first 10 cases of each surgeon shall be excluded from the main analysis. The results of the first 10 cases ("learning curve") shall be assessed separately and compared with the "10 plus" cases ("routine cases") as a secondary learning curve analysis. The potential learning curve will be assessed measuring the intraoperative surgery time in reference to the already performed procedures of each surgeon | Intraoperatively | |
Secondary | Intraoperative handling of soft- and hardware components | Aim of this study is also to document any upcoming problems or limitations the operating surgeon has with the new components of the OrthoPilot® Elite hardware system and the new software application TKA 6.0 for the implantation of primary total knee endoprosthesis. Intraoperatively documented results of the navigation system will be recorded and integrated into the final analysis. Potential problems or comments will be analysed descriptively. | Intraoperatively | |
Secondary | (Serious) Adverse Device Effects | As part of the follow-up examination, any upcoming (serious) adverse device events or effects related or not related to the product under investigation, will be documented in the dedicated Case Report Forms. Recorded complications will be categorized and analyzed in order to assess the safety of the OrthoPilot® navigation system | up to 3 months postoperatively |
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