Degenerative OsteoarthritisNCT03817632
Orthopilot Elite Post-Market Clinical Follow-Up
An observational study of Degenerative Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG at 3 sites in Germany.
Trial summary
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy
- What is being tested?
- Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1 and Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
- Type of treatment
- Medical device
- How many people
- 217 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Jul 2019to 29 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant
- Dated and signed informed consent
Who cannot join
- Pregnancy
- Patients < 18 years
- Patients unable to participate at the follow-up examination (physically, mentally)
- Previous joint replacement at the indexed knee
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Uniklinikum Freiburg
Freiburg im Breisgau, 79106
Schönkliniken Klinikum Eilbek
Hamburg, 22081
About this study
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
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty
Read the 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.
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy, Instability, Joint, Stiffness of Knee, Not Elsewhere Classified, Deformity of Knee
- Being tested
- Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1, Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
- Keywords
- Navigation, Computer Assisted Orthopedic Surgery, OrthoPilot®, Total Knee Arthroplasty
- Medical subject headings
- Joint Diseases, Arthritis, Rheumatoid, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1Device
Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1
Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0Device
Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0
| Study group | Role | What they receive |
|---|---|---|
| A Standard | Computer assisted primary total knee replacement with OrthoPilot FS 101 navigation system and Software 5.1 Receives: Device: Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1 | |
| B Elite | Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0 Receives: Device: Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three months postoperatively
Secondary outcomes (7)
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.
Measured: 3 months postoperatively
Improvement of Knee Society Score (KSS)
The KSS score is composed of two subgroups and has a maximum score of 200.
Measured: preoperatively and three months postoperatively
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
Measured: preoperatively and three months postoperatively
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.
Measured: preoperatively and three months postoperatively
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
Measured: Intraoperatively
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.
Measured: Intraoperatively
(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
Measured: up to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Jul 2019
- Primary completion30 Jun 2022
- Study completion29 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817632
- Sponsor's protocol ID
- AAG-O-H-1708
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2019
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03817632
- Acronym / sponsor ID
- AAG-O-H-1708
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy, Instability, Joint, Stiffness of Knee, Not Elsewhere Classified, Deformity of Knee
- Keywords
- Navigation, Computer Assisted Orthopedic Surgery, OrthoPilot®, Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 29 Oct 2022 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Standard | – | Device: Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1Computer assisted primary total knee replacement with OrthoPilot FS 101 navigation system and Software 5.1 |
| B Elite | – | Device: Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (2 listed)
- Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant
- Dated and signed informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Patients < 18 years
- Patients unable to participate at the follow-up examination (physically, mentally)
- Previous joint replacement at the indexed knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1 | Device | A Standard |
| Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0 | Device | B Elite |
Primary outcome
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
7 secondary outcomes
Lower limb alignment of the knee prosthesis in reference to the mechanical leg axis
Time frame: 3 months postoperatively
Improvement of Knee Society Score (KSS)
Time frame: preoperatively and three months postoperatively
Improvement of Oxford Knee Score (OKS)
Time frame: preoperatively and three months postoperatively
Improvement of Quality of Life (EQ-5D-5L)
Time frame: preoperatively and three months postoperatively
Learning Curve
Time frame: Intraoperatively
Intraoperative handling of soft- and hardware components
Time frame: Intraoperatively
(Serious) Adverse Device Effects
Time frame: up to 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Lower Limb Alignment inside the range of 0±3° (time frame: three months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.