- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03817632
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
Study Overview
Status
Conditions
Detailed Description
The study is designed as a prospective, non-interventional, multicenter, comparative cohort study. The product under investigation will be used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
The study design is based on a two-arms design. The patients for the both groups will be recruited consecutively, starting with group A. The study will prove the equivalence of the groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis) and any deviation >3° from neutral alignment is defined as an outlier.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Dresden, Germany, 01307
- Universitätsklinikum Carl Gustav Carus
-
Freiburg, Germany, 79106
- Uniklinikum Freiburg
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Hamburg, Germany, 22081
- Schönkliniken Klinikum Eilbek
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A Standard
Computer assisted primary total knee replacement with OrthoPilot FS 101 navigation system and Software 5.1
|
Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1
|
B Elite
Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
|
Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Lower Limb Alignment inside the range of 0±3°
Time Frame: three months postoperatively
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower limb alignment of the knee prosthesis in reference to the mechanical leg axis
Time Frame: 3 months postoperatively
|
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
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Improvement of Knee Society Score (KSS)
Time Frame: preoperatively and three months postoperatively
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The KSS score is composed of two subgroups and has a maximum score of 200.
|
preoperatively and three months postoperatively
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Improvement of Oxford Knee Score (OKS)
Time Frame: preoperatively and three months postoperatively
|
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
|
Improvement of Quality of Life (EQ-5D-5L)
Time Frame: preoperatively and three months postoperatively
|
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
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Learning Curve
Time Frame: Intraoperatively
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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
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Intraoperatively
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Intraoperative handling of soft- and hardware components
Time Frame: Intraoperatively
|
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.
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Intraoperatively
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(Serious) Adverse Device Effects
Time Frame: up to 3 months postoperatively
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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
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up to 3 months postoperatively
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAG-O-H-1708
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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