Osteoarthritis, KneeNCT04199481
Univation XM France
An observational study of Osteoarthritis, Knee and Osteoarthrosis of Knee, run by Aesculap AG at 1 site in France.
Trial summary
The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthrosis of Knee, Arthritis Knee
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2020to Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Patient has received a primary mobile bearing UKA at the study site between January 2017 and December 2018 using the product under investigation
- Patient's written consent and willingness to participate at the clinical study and the follow-up examinations
Who cannot join
- Pregnancy
- Patient Age <18 years at the time of the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational, Monocentre 5-year Follow-up Clinical Trial on a Historical Consecutive Cohort of Unicompartmental Knee Arthroplasty Patients Treated With the Mobile Bearing Unicondylar Knee Prosthesis Univation XM
The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. This design is selected to quicker realize follow-up data as patients have already been treated in the past.
As the mobile version of the implant is not widely used, the study will be set up as a monocentric study in France. The clinical hypothesis of the study is that patients who are treated with the product under investigation have a similar outcome and survival rate in comparison to other established unicondylar knee systems on the market. Comparison for the later evaluation will be taken out of recent orthopaedic registries.
- Conditions
- Osteoarthritis, Knee, Osteoarthrosis of Knee, Arthritis Knee, Unicompartmental Knee Arthroplasty
- Keywords
- unicompartmental knee arthroplasty, retrospective study, Knee Society Score
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate of the Implant
Revision-free survival rate after 5 years according to Kaplan-Meier
Measured: 5 years after surgery
Secondary outcomes (5)
Development of Knee joint function
Postoperative Development of knee joint function measured with the Knee Society Score (KSS). The KSS is composed of two subgroups "Knee Score" and "Function Score"; both parts have a maximum score of 100, where higher values represent better results.
Measured: in the postoperative course, up to 5 years after surgery
Development of Oxford Knee Score
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: in the postoperative course, up to 5 years after surgery
Intraoperative/surgery Data
Surgical and intraoperative data collected will include the date and duration of the surgery, selected implants and sizes, blood loss and implant descriptions. Surgical duration is to be measured from the time of incision to the time of skin closure, skin-to-skin. All potential Adverse Events will be collected during the surgical procedure and/or from the surgical record and will be documented on the intra-operative Evaluation Form.
Measured: intraoperative
Radiographic evaluation
The outcome and function of a knee 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; The aim of a postoperative alignment within 3° varus to 3° valgus will be assessed using long leg x-rays up to 5 years after surgery
Measured: in the postoperative course, up to 5 years after surgery
Rate of Serious Adverse Events
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 univation XM prosthesis
Measured: in the postoperative course, up to 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study startAug 2020 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: Study stopped due to product discontinuation by manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B. Braun Medical SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199481
- Sponsor's protocol ID
- AAG-O-H-1822
- Status last verified
- Jul 2020
- First submitted
- 12 Dec 2019
- Last updated
- 23 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Monocentre 5-year Follow-up Clinical Trial on a Historical Consecutive Cohort of Unicompartmental Knee Arthroplasty Patients Treated With the Mobile Bearing Unicondylar Knee Prosthesis Univation XM
- ClinicalTrials.gov ID
- NCT04199481
- Acronym / sponsor ID
- AAG-O-H-1822
- Conditions
- Osteoarthritis, Knee, Osteoarthrosis of Knee, Arthritis Knee, Unicompartmental Knee Arthroplasty
- Keywords
- unicompartmental knee arthroplasty, retrospective study, Knee Society Score
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study stopped due to product discontinuation by manufacturer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B. Braun Medical SA
- Study start
- Aug 2020 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 16 Dec 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.
The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. This design is selected to quicker realize follow-up data as patients have already been treated in the past.
As the mobile version of the implant is not widely used, the study will be set up as a monocentric study in France. The clinical hypothesis of the study is that patients who are treated with the product under investigation have a similar outcome and survival rate in comparison to other established unicondylar knee systems on the market. Comparison for the later evaluation will be taken out of recent orthopaedic registries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (2 listed)
- Patient has received a primary mobile bearing UKA at the study site between January 2017 and December 2018 using the product under investigation
- Patient's written consent and willingness to participate at the clinical study and the follow-up examinations
Key exclusion criteria (2 listed)
- Pregnancy
- Patient Age <18 years at the time of the surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival Rate of the Implant
Time frame: 5 years after surgery
Revision-free survival rate after 5 years according to Kaplan-Meier
5 secondary outcomes
Development of Knee joint function
Time frame: in the postoperative course, up to 5 years after surgery
Development of Oxford Knee Score
Time frame: in the postoperative course, up to 5 years after surgery
Intraoperative/surgery Data
Time frame: intraoperative
Radiographic evaluation
Time frame: in the postoperative course, up to 5 years after surgery
Rate of Serious Adverse Events
Time frame: in the postoperative course, up to 5 years after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Osteoarthrosis of Knee, run by Aesculap AG at 1 site in France.
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 2 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: withdrawn, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Survival Rate of the Implant (time frame: 5 years after surgery). 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 23 Jul 2020.