ArthroplastyNCT04728542
ORIGIN® vs. VANGUARD® PS Observational Study
An observational study of Arthroplasty and Replacement, run by Symbios Orthopedie SA at 1 site in Germany.
Trial summary
The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- ORIGIN PS System and VANGUARD PS System
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2021to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Non-inflammatory degenerative and inflammatory knee joint disease
Inclusion/exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center of Johannes Gutenberg-University Mainz
Mainz, 55131
Lukas Eckhard
Philipp Drees, Dr
About this study
Official title: A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.
The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.
Read the detailed description
This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- ORIGIN PS System, VANGUARD PS System
- Keywords
- Arthroplasty, Knee, Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIGIN PS SystemDevice
70 surgeries with the ORIGIN PS System
VANGUARD PS SystemDevice
70 surgeries with the VANGUARD System
| Study group | Role | What they receive |
|---|---|---|
| Origine | 70 subjects with the ORIGIN PS System Receives: Device: ORIGIN PS System | |
| Vanguard | 70 subjects with the VANGUARD System Receives: Device: VANGUARD PS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten Joint Score
12 questions and measure the ability of the patient to forget their operated knee after the surgery.
Measured: Preoperative, 1 year, and 2 years visits
The Self-Administered Patient Satisfaction Scale
Patients' overall satisfaction with surgery, the extent of pain relief, the ability to perform home or yard work, and the ability to perform recreational activities.
Measured: Preoperative, 1 year, and 2 years visits
Secondary outcomes (5)
Oxford Knee Score (OKS)
Patient reported scores This Quality of Life score was developed in 1998 and validated to measure pain and function after total knee replacement. It consists of 12 questions about pain, function and mobility of the knee joint.
Each question scores from 1 to 5 (1 the best and 5 the worst) and the sum of all the scores is deducted from 60 points. The best total is 48 points and the worst is 0.
Measured: Preoperative, 1 year, and 2 years visits
EQ-5D-5L
Patient reported scores.
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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. 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.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: Preoperative, 1 year, and 2 years visits
Knee Society clinical rating system (KSS) Objective Knee Indicators
Surgeon reported score.
It consists of 4 questions regarding the alignment and mobility of the knee joint:
"Alignment" has a maximum of 25 points and is determined on a weight-bearing AP radiograph measuring the femoral-tibial (Anatomic) axis.
"Instability" allows a maximum of 25 points for a knee that is stable in the coronal and saggital axis.
"Joint Motion" allows one point for each 5° of joint motion. Unlike the old scoring system that allowed a maximum of 25 points the new system allows greater than 25 points for patients with greater than 125° of motion. There are deductions for flexion contracture and extension lag. The presence of recurvatum is not specifically addressed however patients with recurvatum will have significant ligament laxity in other planes that is captured in the
"Instability" category of the objective score. Maximum allowable points 25+
Measured: Preoperative, 1 year, and 2 years visits
Single Leg Stance test
Surgeon reported score. It is used to assess static postural and balance control. It is a balance assessement that is widely used in clinical settings to monitor neurological and musculoskeletal conditions.
It measures the duration of exercices with eyes opened and closed in seconds.
Measured: Preoperative, 1 year, and 2 years visits
Time Up & Go tests
Surgeon reported score It is a simple test to assess a person's mobility and requires both static and dynamic balance (e.g. Getting up from a chair with armrests, Make a U turn...) The criteria are : able - unable
Measured: Preoperative, 1 year, and 2 years visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start25 Mar 2021
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArthroplastyStudies 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
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Symbios Orthopedie SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Drees, Prof, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728542
- Sponsor's protocol ID
- CLIN-G-010
- Other IDs
- 2019-14580, 2019
- Status last verified
- Oct 2024
- First submitted
- 20 Jan 2021
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carlson VR, Post ZD, Orozco FR, Davis DM, Lutz RW, Ong AC. When Does the Knee Feel Normal Again: A Cross-Sectional Study Assessing the Forgotten Joint Score in Patients After Total Knee Arthroplasty. J Arthroplasty. 2018 Mar;33(3):700-703. doi: 10.1016/j.arth.2017.09.063. Epub 2017 Oct 7.
PubMed 29108793Wheatley B, Nappo K, Fisch J, Rego L, Shay M, Cannova C. Early outcomes of patient-specific posterior stabilized total knee arthroplasty implants. J Orthop. 2018 Dec 6;16(1):14-18. doi: 10.1016/j.jor.2018.11.003. eCollection 2019 Jan-Feb.
PubMed 30765928Kahlenberg CA, Lyman S, Joseph AD, Chiu YF, Padgett DE. Comparison of patient-reported outcomes based on implant brand in total knee arthroplasty: a prospective cohort study. Bone Joint J. 2019 Jul;101-B(7_Supple_C):48-54. doi: 10.1302/0301-620X.101B7.BJJ-2018-1382.R1.
PubMed 31256639
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.
- ClinicalTrials.gov ID
- NCT04728542
- Acronym / sponsor ID
- CLIN-G-010
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Arthroplasty, Knee, Prosthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Symbios Orthopedie SAIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Jan 2021 (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 objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.
Detailed description
This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Origine | – | Device: ORIGIN PS System70 subjects with the ORIGIN PS System |
| Vanguard | – | Device: VANGUARD PS System70 subjects with the VANGUARD System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-inflammatory degenerative and inflammatory knee joint disease
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 |
|---|---|---|
| ORIGIN PS System70 surgeries with the ORIGIN PS System | Device | Origine |
| VANGUARD PS System70 surgeries with the VANGUARD System | Device | Vanguard |
Primary outcome
Forgotten Joint Score
Time frame: Preoperative, 1 year, and 2 years visits
12 questions and measure the ability of the patient to forget their operated knee after the surgery.
The Self-Administered Patient Satisfaction Scale
Time frame: Preoperative, 1 year, and 2 years visits
Patients' overall satisfaction with surgery, the extent of pain relief, the ability to perform home or yard work, and the ability to perform recreational activities.
5 secondary outcomes
Oxford Knee Score (OKS)
Time frame: Preoperative, 1 year, and 2 years visits
EQ-5D-5L
Time frame: Preoperative, 1 year, and 2 years visits
Knee Society clinical rating system (KSS) Objective Knee Indicators
Time frame: Preoperative, 1 year, and 2 years visits
Single Leg Stance test
Time frame: Preoperative, 1 year, and 2 years visits
Time Up & Go tests
Time frame: Preoperative, 1 year, and 2 years visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 29108793Carlson VR, Post ZD, Orozco FR, Davis DM, Lutz RW, Ong AC. When Does the Knee Feel Normal Again: A Cross-Sectional Study Assessing the Forgotten Joint Score in Patients After Total Knee Arthroplasty. J Arthroplasty. 2018 Mar;33(3):700-703. doi: 10.1016/j.arth.2017.09.063. Epub 2017 Oct 7.
- Background: PubMed 30765928Wheatley B, Nappo K, Fisch J, Rego L, Shay M, Cannova C. Early outcomes of patient-specific posterior stabilized total knee arthroplasty implants. J Orthop. 2018 Dec 6;16(1):14-18. doi: 10.1016/j.jor.2018.11.003. eCollection 2019 Jan-Feb.
- Background: PubMed 31256639Kahlenberg CA, Lyman S, Joseph AD, Chiu YF, Padgett DE. Comparison of patient-reported outcomes based on implant brand in total knee arthroplasty: a prospective cohort study. Bone Joint J. 2019 Jul;101-B(7_Supple_C):48-54. doi: 10.1302/0301-620X.101B7.BJJ-2018-1382.R1.
- Individual participant dataSharing planned: No
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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.
Philippe Drees, Prof principal investigator
Johannes Gutenberg University Mainz
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 Arthroplasty and Replacement, run by Symbios Orthopedie SA at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 4 Oct 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Eckhard (+496131177302, lukas.eckhard@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forgotten Joint Score (time frame: Preoperative, 1 year, and 2 years visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04728542, which also lists 3 linked publications.
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 4 Oct 2024.