Degenerative OsteoarthritisNCT02802085
VEGA Prospective Kiel
An observational study of Degenerative Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG at 1 site in Germany.
Trial summary
Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation. For this PMCF only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been or are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- VEGA Knee
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Feb 2018
- 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 primary TKA at the study site five to six years ago using the product under investigation because of the following severe knee joint conditions that could not be treated through other therapies:
- degenerative osteoarthritis,
- rheumatoid arthritis,
- posttraumatic arthritis,
- symptomatic knee instability, knee stiffness or deformation of the knee joint
- Age at the time of surgery ≥ 18 years
- Patient signed informed consent
Who cannot join
- Age younger than 18 years at the time of surgery
- Any prior joint replacement at the index knee
- Patient did not sign informed consent
- All cases not listed under indications (according to IfU)
- All cases showing any contraindication (according to IfU)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational 5 Year Follow-up on a Historical Consecutive Cohort of 100 Primary Total Knee Arthroplasty (TKA) Cases Treated With the Posterior-stabilized VEGA System® PS
Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation.
For this PMCF only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been or are to be carried out (acc. to MPG §23b).
Read the detailed description
This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® VEGA System® PS components under routine conditions. The VEGA System® PS is an established TKA design, and there is a long-lasting experience in the use of PS components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been and are to be carried out (acc. to MPG §23b). This voluntary NIS is part of the post-marketing surveillance for the product under investigation.
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis
- Being tested
- VEGA Knee
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, TKA, TKR, Stiffness of Knee, Deformity, Knee Joint, Instability, Post-traumatic, Arthrosis
- Medical subject headings
- Joint Diseases, Arthritis, Rheumatoid, Congenital Abnormalities, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGA KneeDevice
TKA
| Study group | Role | What they receive |
|---|---|---|
| Knee Arthroplasty | Vega Knee Arthroplasty Receives: Device: VEGA Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision (non-survival) rate
The objective of the study is to collect clinical 5 year outcome information on the product under investigation when used in routine clinical practice.
Measured: 5 years
Secondary outcomes (6)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5 year postoperative assessment
Measured: 5 years
Physical Component Summary (PCS-12) of SF-12® Health Survey (SF-12)
Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment
Measured: 5 years
Mental Component Summary (MCS-12) of SF-12® Health Survey (SF-12)
Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment
Measured: 5 years
Pain
Changes of anterior knee pain according to the Waters and Bentley rating system from the preoperative baseline to the 5 year postoperative assessment
Measured: 5 years
Knee Score (KS) of Knee Society Score (KSS)
The Knee Score (KS) of the Knee Society Score (KSS) at the 5 year postoperative assessment
Measured: 5 years
Functional Score (FS) of Knee Society Score (KSS)
The Functional Score (FS) of the Knee Society Score (KSS) at the 5 year postoperative assessment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative OsteoarthritisStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Frictionless GmbH
- Responsible party
- Sponsor
- Investigators
- Ludger Gerdesmeyer, Professor, Principal investigator, orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802085
- Sponsor's protocol ID
- AAG-I-H-1319
- Status last verified
- Jan 2019
- First submitted
- 25 May 2016
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gerdesmeyer L, Glowalla C, Lasic I, Al Muderis M, Weuster M, Klueter T. The Vega advanced third generation posterior stabilized total knee arthroplasty system enables the restoration of range of motion for high demanding daily activities - A 5-years follow-up study. PLoS One. 2024 May 13;19(5):e0302885. doi: 10.1371/journal.pone.0302885. eCollection 2024.
PubMed 38739584
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational 5 Year Follow-up on a Historical Consecutive Cohort of 100 Primary Total Knee Arthroplasty (TKA) Cases Treated With the Posterior-stabilized VEGA System® PS
- ClinicalTrials.gov ID
- NCT02802085
- Acronym / sponsor ID
- AAG-I-H-1319
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, TKA, TKR, Stiffness of Knee, Deformity, Knee Joint, Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- Frictionless GmbH
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 16 Jun 2016 (estimated)
- 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.
Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation.
For this PMCF only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been or are to be carried out (acc. to MPG §23b).
Detailed description
This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® VEGA System® PS components under routine conditions. The VEGA System® PS is an established TKA design, and there is a long-lasting experience in the use of PS components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been and are to be carried out (acc. to MPG §23b). This voluntary NIS is part of the post-marketing surveillance for the product under investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Arthroplasty | – | Device: VEGA KneeVega Knee Arthroplasty |
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 (7 listed)
- Patient has received primary TKA at the study site five to six years ago using the product under investigation because of the following severe knee joint conditions that could not be treated through other therapies:
- degenerative osteoarthritis,
- rheumatoid arthritis,
- posttraumatic arthritis,
- symptomatic knee instability, knee stiffness or deformation of the knee joint
Key exclusion criteria (5 listed)
- Age younger than 18 years at the time of surgery
- Any prior joint replacement at the index knee
- Patient did not sign informed consent
- All cases not listed under indications (according to IfU)
- All cases showing any contraindication (according to IfU)
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 |
|---|---|---|
| VEGA KneeTKA | Device | Knee Arthroplasty |
Primary outcome
Revision (non-survival) rate
Time frame: 5 years
The objective of the study is to collect clinical 5 year outcome information on the product under investigation when used in routine clinical practice.
6 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 5 years
Physical Component Summary (PCS-12) of SF-12® Health Survey (SF-12)
Time frame: 5 years
Mental Component Summary (MCS-12) of SF-12® Health Survey (SF-12)
Time frame: 5 years
Pain
Time frame: 5 years
Knee Score (KS) of Knee Society Score (KSS)
Time frame: 5 years
Functional Score (FS) of Knee Society Score (KSS)
Time frame: 5 years
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 23 Jan 2019.
- Derived from this study: PubMed 38739584Gerdesmeyer L, Glowalla C, Lasic I, Al Muderis M, Weuster M, Klueter T. The Vega advanced third generation posterior stabilized total knee arthroplasty system enables the restoration of range of motion for high demanding daily activities - A 5-years follow-up study. PLoS One. 2024 May 13;19(5):e0302885. doi: 10.1371/journal.pone.0302885. eCollection 2024.
- 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. This study is not recruiting at the moment.
Ludger Gerdesmeyer, Professor principal investigator
orthopedics
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 Degenerative Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG 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?
The sponsor lists 7 inclusion and 5 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 23 Jan 2019. 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?
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?
Revision (non-survival) rate (time frame: 5 years). 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 NCT02802085, which also lists 1 linked publication.
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 Jan 2019.