OsteoarthritisNCT00698854
A Clinical Investigation of the Vanguard™ Complete Knee System
An observational study of Osteoarthritis and Traumatic Arthritis, run by Zimmer Biomet at 8 sites in United States.
Trial summary
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- Vanguard™ Complete Knee System and Vanguard™ Patient-Specific Femur
- Type of treatment
- Medical device
- How many people
- 552 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2004to Mar 2024
- 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: Patients in need of relief from painful or disabling joint disease
Who may be able to join
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity
- Correction or revision of unsuccessful osteotomy, or arthrodesis
- Patient selection factors to be considered include:
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions
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- Including control of weight and activity level
- Good nutritional state of the patient
- Patient must have reached full skeletal maturity
Who cannot join
- Absolute contraindications include:
- Infection
- Sepsis
- Osteomyelitis
- Failure of a previous joint replacement
- Relative contraindications include:
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- 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
- Additional exclusion criteria includes: failure of a previous joint replacement
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Advanced Orthopedic Specialists
Cape Girardeau, Missouri, 63701
Physicians Clinic of Iowa Orthopedics
Cedar Rapids, Iowa, 52403
Orthopedic Associates
Fishersville, Virginia, 22939
Texas Orthopedic Specialists
Grapevine, Texas, 76015
Othopaedic & Sports Medicine Clinic of Monroe
Monroe, Wisconsin, 53566
Orthopaedic Associates of Rochester
Rochester, New York, 14626
The Orthopaedic Center
Rockville, Maryland, 20850
Spokane Orthopedics
Spokane, Washington, 99207
About this study
Official title: A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
Read the detailed description
This is a 10-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, immediate post-operative, 6 Month, 1 Year, 3 Year,5 Year, 7 year, and 10 year visits to check on the function, range of motion, and radiographic assessment of their total knee device.
The Vanguard Knee is an FDA cleared device, and has been on the market since 2004.
- Conditions
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Lower Limb Deformity, Complications, Arthroplasty
- Being tested
- Vanguard™ Complete Knee System, Vanguard™ Patient-Specific Femur
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Knee Arthritis
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanguard™ Complete Knee SystemDevice
Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)
Vanguard™ Patient-Specific FemurDevice
Also called Vanguard Select
Primary Total Knee System used with Signature technique to provide a patient-specific femur
| Study group | Role | What they receive |
|---|---|---|
| Vanguard™ Complete Knee System | Vanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS) Receives: Device: Vanguard™ Complete Knee System | |
| Vanguard™ Patient-Specific Femur | Vanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur Receives: Device: Vanguard™ Patient-Specific Femur |
What is being measured
The primary outcome is the main question the study is designed to answer.
KSS
Knee Society Score Assessment
Measured: 10 year
Secondary outcomes (2)
Radiographic Information
Radiographic Evaluation Report
Measured: 10 years
Survivorship
Knee Society Score Assessment
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 posted17 Jun 2008 (estimated)
- Study startMar 2004
- Primary completionJan 2021
- Study completionMar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kacy C Arnold, RN MBA, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698854
- Sponsor's protocol ID
- ORTHO.CR.K005
- Status last verified
- Sep 2024
- First submitted
- 13 Jun 2008
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System
- ClinicalTrials.gov ID
- NCT00698854
- Acronym / sponsor ID
- ORTHO.CR.K005
- Conditions
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Lower Limb Deformity, Complications, Arthroplasty
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Knee Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jan 2021 (actual)
- Study completion
- Mar 2024 (actual)
- First posted
- 17 Jun 2008 (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.
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
Detailed description
This is a 10-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, immediate post-operative, 6 Month, 1 Year, 3 Year,5 Year, 7 year, and 10 year visits to check on the function, range of motion, and radiographic assessment of their total knee device.
The Vanguard Knee is an FDA cleared device, and has been on the market since 2004.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanguard™ Complete Knee System | – | Device: Vanguard™ Complete Knee SystemVanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS) |
| Vanguard™ Patient-Specific Femur | – | Device: Vanguard™ Patient-Specific FemurVanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of relief from painful or disabling joint disease
Key inclusion criteria (9 listed)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity
- Correction or revision of unsuccessful osteotomy, or arthrodesis
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions
Key exclusion criteria (15 listed)
- Infection
- Sepsis
- Osteomyelitis
- Failure of a previous joint replacement
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
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™ Complete Knee SystemPrimary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS) | Device | Vanguard™ Complete Knee System |
| Vanguard™ Patient-Specific FemurAlso: Vanguard SelectPrimary Total Knee System used with Signature technique to provide a patient-specific femur | Device | Vanguard™ Patient-Specific Femur |
Primary outcome
KSS
Time frame: 10 year
Knee Society Score Assessment
2 secondary outcomes
Radiographic Information
Time frame: 10 years
Survivorship
Time frame: 10 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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Kacy C Arnold, RN MBA study director
Zimmer Biomet
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Traumatic Arthritis, run by Zimmer Biomet at 8 sites in United States.
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 9 inclusion and 15 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
KSS (time frame: 10 year). 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 19 Sep 2024.