Degenerative OsteoarthritisAPT-VEGA_KINCT02756702
All Polyethylene Tibia-VEGA Kiel
An observational study of Degenerative Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG at 1 site in Germany.
Trial summary
Obligatory 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 will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Post-traumatic; Arthrosis
- What is being tested?
- All-Poly
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to 6 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Patients requiring primary TKA because of severe knee joint conditions that cannot be treated through other therapies;
- degenerative osteoarthritis;
- rheumatoid arthritis;
- posttraumatic arthritis;
- symptomatic knee instability;
- knee stiffness or deformation of the knee joint;
- Age ≥ 18 years;
- Patient signed informed consent
Who cannot join
- Age younger than 18 years
- Any prior joint replacement at the index knee
- Unable or unwilling to return for postoperative follow-up
- Patient did not sign informed consent
- Joint conditions that can be treated by reconstructive surgery (e.g. osteotomy)
- Acute or chronic infections near the joint, or systemic infections
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- Secondary diseases that could influence joint implant functionality
- Systemic diseases and metabolic disorders
- Severe osteoporosis or osteomalacia
- Severely damaged bone structures that could prevent stable implantation of implant components
- Bone tumors in the region of implant fixation
- Bone malformations, axial misalignments or other bone conditions that rule out implantation of a prosthetic joint
- Expected overload on the joint implant, especially due to high patient weight or intense physical strain and activity
- Dependency on pharmaceutical drugs, drug abuse, or alcoholism
- Fever, infection or inflammation (systemic or local)
- Pregnancy
- Mental illness
- Severe osteopenia (or any other medical or surgical finding) that would preclude any benefit from the implants
- Combination with implant components from other manufacturers
- Inadequate patient compliance
- Foreign body sensitivity to the implant materials
- All cases not listed under indications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational 5 Year Follow-up on a Consecutive Cohort of 70 Primary Total Knee Arthroplasty (TKA) Cases Treated With All-polyethylene Tibia (APT) Components of the Posterior-stabilized VEGA System PS
Obligatory 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 will be used within their intended purpose and no additional invasive or other stressful examinations 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® APT 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 PE for TKA in general and for APT components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b). As part of the post marketing surveillance plan an obligatory Post-Marketing Clinical Follow-up (PMCF) is required for the product under investigation.
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Post-traumatic; Arthrosis, Other Instability, Knee, Stiffness of Knee, Not Elsewhere Classified, Deformity of Knee Joint
- Being tested
- All-Poly
- Keywords
- TKA, TKR, All-Poly, posterior stabilized
- Medical subject headings
- Joint Diseases, Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-PolyDevice
Also called Total Knee Replacement
Implantation of the VEGA PS using all-polyethylene tibia components
| Study group | Role | What they receive |
|---|---|---|
| All-Poly | All-polyethylene tibia VEGA System® PS - A posterior stabilized total knee arthroplasty (TKA) system using solely all-polyethylene tibia components Receives: Device: All-Poly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision Rate
The objective of the study is to collect clinical midterm outcome information on the product under investigation when used in routine clinical practice.
Measured: 5 years
Secondary outcomes (5)
Complication/Adverse Event rate
Cumulative Number of Complications / Adverse Events of any reason over the period of follow-up
Measured: 5 years
KOOS (Knee Osteoarthritis Outcome Score)
Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5-year postoperative
Measured: 5 years
KSS (Knee Society Score)
Changes of the Knee Society Score (KSS) with its Knee and Functional Score (KS and FS) from the preoperative baseline to the 5-year postoperative assessment
Measured: 5 years
SF-12® Health Survey (SF-12)
Changes of the total SF-12® Health Survey (SF-12) components Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) from the preoperative baseline to the 5-year postoperative assessment
Measured: 5 years
Change of anterior knee pain over follow-up period
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completion6 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.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Frictionless GmbH, Kiel
- Responsible party
- Sponsor
- Investigators
- Ludger Gerdesmeyer, Professor, Principal investigator, orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756702
- Sponsor's protocol ID
- AAG-O-H-1527
- Acronym
- APT-VEGA_KI
- Status last verified
- Jun 2023
- First submitted
- 27 Apr 2016
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational 5 Year Follow-up on a Consecutive Cohort of 70 Primary Total Knee Arthroplasty (TKA) Cases Treated With All-polyethylene Tibia (APT) Components of the Posterior-stabilized VEGA System PS
- ClinicalTrials.gov ID
- NCT02756702
- Acronym / sponsor ID
- APT-VEGA_KI / AAG-O-H-1527
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Post-traumatic; Arthrosis, Other Instability, Knee, Stiffness of Knee, Not Elsewhere Classified, Deformity of Knee Joint
- Keywords
- TKA, TKR, All-Poly, posterior stabilized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- Frictionless GmbH, Kiel
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 29 Apr 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.
Obligatory 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 will be used within their intended purpose and no additional invasive or other stressful examinations 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® APT 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 PE for TKA in general and for APT components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b). As part of the post marketing surveillance plan an obligatory Post-Marketing Clinical Follow-up (PMCF) is required for the product under investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All-Poly | – | Device: All-PolyAll-polyethylene tibia VEGA System® PS - A posterior stabilized total knee arthroplasty (TKA) system using solely all-polyethylene tibia components |
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 (8 listed)
- Patients requiring primary TKA because of severe knee joint conditions that cannot be treated through other therapies;
- degenerative osteoarthritis;
- rheumatoid arthritis;
- posttraumatic arthritis;
- symptomatic knee instability;
Key exclusion criteria (22 listed)
- Age younger than 18 years
- Any prior joint replacement at the index knee
- Unable or unwilling to return for postoperative follow-up
- Patient did not sign informed consent
- Joint conditions that can be treated by reconstructive surgery (e.g. osteotomy)
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 |
|---|---|---|
| All-PolyAlso: Total Knee ReplacementImplantation of the VEGA PS using all-polyethylene tibia components | Device | All-Poly |
Primary outcome
Revision Rate
Time frame: 5 years
The objective of the study is to collect clinical midterm outcome information on the product under investigation when used in routine clinical practice.
5 secondary outcomes
Complication/Adverse Event rate
Time frame: 5 years
KOOS (Knee Osteoarthritis Outcome Score)
Time frame: 5 years
KSS (Knee Society Score)
Time frame: 5 years
SF-12® Health Survey (SF-12)
Time frame: 5 years
Change of anterior knee pain over follow-up period
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 26 Jun 2023.
- 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 8 inclusion and 22 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 26 Jun 2023. 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 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?
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 26 Jun 2023.