Knee OsteoarthritisNCT04076202
Clinical Evaluation of Vanguard DD RP
A study testing Cementless Vanguard DD RP in people with Knee Osteoarthritis and Post-traumatic Osteoarthritis, run by Zimmer Biomet at 1 site in Austria.
Trial summary
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Cementless Vanguard DD RP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteAustria
- Study dates
- 11 Jul 2013to 31 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients scheduled to undergo primary total knee replacement:
- with painful and disabled knee joint resulting from any of the following diagnoses:
- Osteoarthritis,
- Traumatic arthritis,
- Rheumatoid arthritis with one or more compartments involved.
- Correction of varus, valgus, or posttraumatic deformity.
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- Correction or revision of unsuccessful osteotomy or arthrodesis.
- Need to obtain pain relief and improve function.
- Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
- A good nutritional state of the patient.
- Full skeletal maturity of the patient, patients who are at least 18 years of age.
- Patients of either sex.
- Consent form read, understood, and signed by patient.
Who cannot join
- Absolute contraindications include the following diagnoses:
- Infection
- Osteomyelitis
- Previous partial or total prosthetic knee replacement on the operative side
- Skeletal immaturity of the patient
- Sepsis
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- Patients who are less than 18 years of age
- Relative contraindications include:
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
- metabolic disorders which may impair bone formation,
- osteomalacia,
- distant foci of infections which may spread to the implant site,
- rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
- vascular insufficiency, muscular atrophy, neuromuscular disease,
- incomplete or deficient soft tissue surrounding the knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Vanguard Deep Dish Rotating Platform Knee - Cementless Fixation With Finned Stem
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population
Read the detailed description
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.
- Being tested
- Cementless Vanguard DD RP
- Keywords
- Knee replacement, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cementless Vanguard DD RPDevice
Patients treated with the Cementless Vanguard DD RP knee implant
| Study group | Role | What they receive |
|---|---|---|
| Cementless Vanguard DD RP | Experimental | Patients receiving a total knee prosthesis Receives: Device: Cementless Vanguard DD RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
The performance will be assessed by evaluation of the rate of aseptic loosening of femoral or tibial components within 2 years follow up.
Measured: 2 years
Secondary outcomes (2)
Patient benefits
Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS evaluates both short-term and long-term consequences of knee injury.The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: 10 years
Patient benefits
Patient benefit will be evaluated by means of European Quality of Life (EuroQol) in 5 Dimensions (EQ-5D) patient questionnaire. The questionnaire contains a descriptive system and the EQ Visual Analogue scale (VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. Higher EQ-5D score values indicate better outcome.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start11 Jul 2013
- Primary completion26 Aug 2018
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sabine Illi, PhD, Study chair, Clinical Evidence ManagerTobias Gotterbarm, Prof. Dr., Principal investigator, Kepler Universitäts Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076202
- Sponsor's protocol ID
- BMETEU.CR.EU 13
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2019
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Vanguard Deep Dish Rotating Platform Knee - Cementless Fixation With Finned Stem
- ClinicalTrials.gov ID
- NCT04076202
- Acronym / sponsor ID
- BMETEU.CR.EU 13
- Keywords
- Knee replacement, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2013 (actual)
- Primary completion
- 26 Aug 2018 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Sep 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.
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population
Detailed description
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cementless Vanguard DD RP | Experimental | Device: Cementless Vanguard DD RPPatients receiving a total knee prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients scheduled to undergo primary total knee replacement:
- Need to obtain pain relief and improve function.
- Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
- A good nutritional state of the patient.
- Full skeletal maturity of the patient, patients who are at least 18 years of age.
Key exclusion criteria (16 listed)
- Absolute contraindications include the following diagnoses:
- Relative contraindications include:
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 |
|---|---|---|
| Cementless Vanguard DD RPPatients treated with the Cementless Vanguard DD RP knee implant | Device | Cementless Vanguard DD RP |
Primary outcome
Performance
Time frame: 2 years
The performance will be assessed by evaluation of the rate of aseptic loosening of femoral or tibial components within 2 years follow up.
2 secondary outcomes
Patient benefits
Time frame: 10 years
Patient benefits
Time frame: 10 years
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 17 May 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.
Sabine Illi, PhD study chair
Clinical Evidence Manager
Tobias Gotterbarm, Prof. Dr. principal investigator
Kepler Universitäts Klinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cementless Vanguard DD RP in people with Knee Osteoarthritis and Post-traumatic Osteoarthritis, run by Zimmer Biomet at 1 site in Austria.
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 13 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 17 May 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 Austria. 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?
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?
Performance (time frame: 2 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 17 May 2024.