OsteoarthritisNCT00753090
Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation
A study testing Vanguard™ Deep Dish Rotating Platform Knee and Vanguard™ Cruciate Retaining Knee in people with Osteoarthritis, run by Zimmer Biomet at 4 sites in 3 countries.
Trial summary
This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Vanguard™ Deep Dish Rotating Platform Knee and Vanguard™ Cruciate Retaining Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jun 2009to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with a pre-operative Knee Society Score of < 70
- Patients scheduled to undergo primary total knee replacement with any of the following indication: Painful and disabled knee joint resulting from osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis; One or more compartments are involved
- 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:
- Patients with a pre-operative Knee Society Score of >= 70
- Infection
- Osteomyelitis
- Previous partial or total prosthetic knee replacement on the operative side
- Patients who are less than 18 years of age
Show all 17Show fewer
- Sepsis
- Patients who had body mass index >= 40
- Relative contraindications include the following factors:
- Uncooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
- Osteoporosis or marked bone loss, which may preclude proper fixation of the prosthesis
- 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, or neuromuscular disease in the affected limb.
- Incomplete or deficient soft tissue surrounding the knee
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Netherlands2 sites
Bravis Ziekenhuis
Roosendaal
Zuyderland Medisch Centrum Sittard-Geleen
Sittard
About this study
This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components.
Read the detailed description
This study is designed to evaluate the safety and efficacy of Vanguard™ Deep Dish Rotating Platform Knee (mobile bearing knee) as compared to Vanguard Cruciate Retaining Knee (fixed bearing knee). This trial was conducted as the randomised, controlled study.
Implant loosening and polyethylene wear in fixed-bearing knee prostheses were recognized as major causes of late failure. The mobile bearing knee have the theoretical advantages of potentially minimizing the polyethylene wear and reducing implant to bone interface stress in order to reduce the incidence of implant loosening. Therefore, the aims of this study were to prove the Vanguard deep dish rotating platform knee is at least as effective in clinical outcome as the widely used current design of knee replacement and better in long term survivorship.
The efficacy of the device was determined by the relief of pain, restoration of function and range of motion. The durability of device was determined by the absence of revision/removal and radiological integrity. To assess the safety of the device, all post operative complications were recorded either device related or otherwise. Patient satisfaction was determined by answers to patient outcome questionnaires (Oxford Knee Score, WOMAC and Lower Extremity Activity Scale).
Between June 29, 2009 and March 5th 2012, 326 cases were enrolled in the study. In total 117 cases were implanted with the Vanguard fixed bearing cruciate retaining knee; the control arm, and 209 cases were implanted with the Vanguard DDRP. All of these patients fulfilled the inclusion/exclusion criteria. From the 4 participating sites, 2 of them (both located in the Netherlands, Zuyderland Hospital and Bravis Hospital) performed a randomized controlled trial (RCT). In the RCT, 40 cases were assigned to the Trial Arm (Vanguard DDRP), and 51 to the control arm (Vanguard CR). The UK site enrolled cases only in the Vanguard DDRP arm and the French site enrolled in both arms, but non-randomized. Total 326 patients are enrolled in the study.
- Conditions
- Osteoarthritis
- Being tested
- Vanguard™ Deep Dish Rotating Platform Knee, Vanguard™ Cruciate Retaining Knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanguard™ Deep Dish Rotating Platform KneeDevice
Total knee replacements with the Vanguard Deep Dish Rotating Platform Knee
Vanguard™ Cruciate Retaining KneeDevice
Total knee replacements with the Vanguard Cruciate Retaining Knee
| Study group | Role | What they receive |
|---|---|---|
| VG DDRP | Experimental | This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee. Receives: Device: Vanguard™ Deep Dish Rotating Platform Knee |
| VG CR | Active comparator | This arm utilizes the Vanguard™ Cruciate Retaining Knee. Receives: Device: Vanguard™ Cruciate Retaining Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
The Knee Society Score (KSS) is a clinician-completed questionnaire and consists of two sub-scores: an Objective score assessing pain, range of motion, anteroposterior and mediolateral stability, along with deductions for higher than normal flexion contracture, extension lag and/or varus/valgus alignment, and a Function score, assessing walking on level ground and walking up and down stairs, along with deductions for support. Each sub-score can range from 0 to 100 points, with higher scores corresponding to better outcomes, classified as Excellent: 80 - 100 points; Good: 70 - 79 points; Fair: 60 - 69 points; Poor: < 60 points.
Measured: 2 years
Secondary outcomes (4)
Knee Society Score
The Knee Society Score (KSS) is a clinician-completed questionnaire and consists of two sub-scores: an Objective score assessing pain, range of motion, anteroposterior and mediolateral stability, along with deductions for higher than normal flexion contracture, extension lag and/or varus/valgus alignment, and a Function score, assessing walking on level ground and walking up and down stairs, along with deductions for support. Each sub-score can range from 0 to 100 points, with higher scores corresponding to better outcomes, classified as Excellent: 80 - 100 points; Good: 70 - 79 points; Fair: 60 - 69 points; Poor: < 60 points.
Measured: 6 weeks, 6 months, annually until all available study patients have completed two-year follow up evaluation and alternating odd years or as needed thereafter up to 10 years
Radiographic Evaluation: Total Varus Angle
Assessment of patient x-rays by each site investigator: Total varus angle. This is defined as the sum of the femoral flexion (the angle between the femoral median axis and the tibial median axis) and the tibial angle (the angle between the anatomical axis of the femur and the tibia in the anteroposterior view of the knee joint) minus 180 degrees.
Measured: 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years postoperative
Radiographic Evaluation: Radiolucency
Assessment of patient x-rays by each site investigator: Radiolucency Femoral Radiolucency is defined as the total nr of participants with radiolucency measured on the femur in each of the 7 different zones.
Tibia AP Radiolucency is defined as total nr of participants with radiolucency in each of the 7 zones measured in the AP view X-ray Tibia lateral Radiolucency defined as total nr of participants with radiolucency in each of the 3 zones in the lateral view X-ray Patella Radiolucency is defined as total nr of participants with radiolucency in each of the 5 zones
Measured: 6 weeks, 6 months, 1, 2, 3, 5, 7 and 10 years postoperative
Survivorship
implant survival at 10 years post surgery and is presented by the number of cases with the implants unrevised
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 posted16 Sep 2008 (estimated)
- Study startJun 2009
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, PhD, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753090
- Sponsor's protocol ID
- BMETEU.CR.EU13B
- Status last verified
- Dec 2024
- First submitted
- 15 Sep 2008
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation
- ClinicalTrials.gov ID
- NCT00753090
- Acronym / sponsor ID
- BMETEU.CR.EU13B
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2009 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components.
Detailed description
This study is designed to evaluate the safety and efficacy of Vanguard™ Deep Dish Rotating Platform Knee (mobile bearing knee) as compared to Vanguard Cruciate Retaining Knee (fixed bearing knee). This trial was conducted as the randomised, controlled study.
Implant loosening and polyethylene wear in fixed-bearing knee prostheses were recognized as major causes of late failure. The mobile bearing knee have the theoretical advantages of potentially minimizing the polyethylene wear and reducing implant to bone interface stress in order to reduce the incidence of implant loosening. Therefore, the aims of this study were to prove the Vanguard deep dish rotating platform knee is at least as effective in clinical outcome as the widely used current design of knee replacement and better in long term survivorship.
The efficacy of the device was determined by the relief of pain, restoration of function and range of motion. The durability of device was determined by the absence of revision/removal and radiological integrity. To assess the safety of the device, all post operative complications were recorded either device related or otherwise. Patient satisfaction was determined by answers to patient outcome questionnaires (Oxford Knee Score, WOMAC and Lower Extremity Activity Scale).
Between June 29, 2009 and March 5th 2012, 326 cases were enrolled in the study. In total 117 cases were implanted with the Vanguard fixed bearing cruciate retaining knee; the control arm, and 209 cases were implanted with the Vanguard DDRP. All of these patients fulfilled the inclusion/exclusion criteria. From the 4 participating sites, 2 of them (both located in the Netherlands, Zuyderland Hospital and Bravis Hospital) performed a randomized controlled trial (RCT). In the RCT, 40 cases were assigned to the Trial Arm (Vanguard DDRP), and 51 to the control arm (Vanguard CR). The UK site enrolled cases only in the Vanguard DDRP arm and the French site enrolled in both arms, but non-randomized. Total 326 patients are enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VG DDRP | Experimental | Device: Vanguard™ Deep Dish Rotating Platform KneeThis arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee. |
| VG CR | Active comparator | Device: Vanguard™ Cruciate Retaining KneeThis arm utilizes the Vanguard™ Cruciate Retaining Knee. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a pre-operative Knee Society Score of < 70
- Patients scheduled to undergo primary total knee replacement with any of the following indication: Painful and disabled knee joint resulting from osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis; One or more compartments are involved
- 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
Key exclusion criteria (17 listed)
- Patients with a pre-operative Knee Society Score of >= 70
- Infection
- Osteomyelitis
- Previous partial or total prosthetic knee replacement on the operative side
- Patients who are less than 18 years of age
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 |
|---|---|---|
| Vanguard™ Deep Dish Rotating Platform KneeTotal knee replacements with the Vanguard Deep Dish Rotating Platform Knee | Device | VG DDRP |
| Vanguard™ Cruciate Retaining KneeTotal knee replacements with the Vanguard Cruciate Retaining Knee | Device | VG CR |
Primary outcome
Knee Society Score
Time frame: 2 years
The Knee Society Score (KSS) is a clinician-completed questionnaire and consists of two sub-scores: an Objective score assessing pain, range of motion, anteroposterior and mediolateral stability, along with deductions for higher than normal flexion contracture, extension lag and/or varus/valgus alignment, and a Function score, assessing walking on level ground and walking up and down stairs, along with deductions for support. Each sub-score can range from 0 to 100 points, with higher scores corresponding to better outcomes, classified as Excellent: 80 - 100 points; Good: 70 - 79 points; Fair: 60 - 69 points; Poor: < 60 points.
4 secondary outcomes
Knee Society Score
Time frame: 6 weeks, 6 months, annually until all available study patients have completed two-year follow up evaluation and alternating odd years or as needed thereafter up to 10 years
Radiographic Evaluation: Total Varus Angle
Time frame: 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years postoperative
Radiographic Evaluation: Radiolucency
Time frame: 6 weeks, 6 months, 1, 2, 3, 5, 7 and 10 years postoperative
Survivorship
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Hassan Achakri, PhD study director
Zimmer Biomet
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanguard™ Deep Dish Rotating Platform Knee and Vanguard™ Cruciate Retaining Knee in people with Osteoarthritis, run by Zimmer Biomet at 4 sites in 3 countries.
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 17 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 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, France, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Knee Society Score (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 30 Jan 2025.