OsteoarthritisGK9BNCT02175576
Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
A study testing Vanguard XP Bicruciate Knee System and Vanguard CR Knee System in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 2 sites in United States.
Trial summary
Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- What is being tested?
- Vanguard XP Bicruciate Knee System and Vanguard CR Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Dec 2020
- 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
- cemented application of components
- bilateral subjects randomized by knee
- patients with pre-existing contralateral knee surgery
- painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
- correction of varus, valgus, or posttraumatic deformity
- sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament
Who cannot join
- cementless application of components
- BMI greater than or equal to 40
- use of Anterior Stabilized Bearings
- patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees
- correction or revision of previous joint replacement procedure on index knee
- infection
Show all 17Show fewer
- sepsis
- osteomyelitis
- Relative exclusion criteria:
- uncooperative patient or patient with neurological disorders who is 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, including the anterior cruciate ligament
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Midwest Orthopaedics at Rush University Medical Center
Chicago, Illinois, 60605
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.
Read the detailed description
Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Lower Limb Deformity, Post-traumatic Deformity, Complications, Arthroplasty
- Being tested
- Vanguard XP Bicruciate Knee System, Vanguard CR Knee System
- 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 XP Bicruciate Knee SystemDevice
The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
Vanguard CR Knee SystemDevice
The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
| Study group | Role | What they receive |
|---|---|---|
| Vanguard XP Bicruciate Knee System | Experimental | 153 patients receive Vanguard XP Bicruciate Knee System Receives: Device: Vanguard XP Bicruciate Knee System |
| Vanguard CR Knee System | Active comparator | 153 patients receive Vanguard CR Knee System Receives: Device: Vanguard CR Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)
Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.
Measured: 12 Months
Secondary outcomes (4)
Modified Knee Society Score
The American Knee Society Score is part clinical exam and part patient administered assessment of the knee. The objective part of the score was collected in the clinic by qualified personnel. The functional and pain components of the score were collected by patient completed questionnaire. Total scores can range from 0 to 200, with higher scores indicating better outcomes.
Measured: 12 months
Revisions/Removals
Number of study device revisions or removals reported during the study.
Measured: 3 years
Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)
Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.
Measured: 12 Months
Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"
Participants answered a survey which asked how they they would describe their satisfaction with their new joint. Options for answers included "I have never been happy," "Ok - but not perfect," "Happy," and "Very Happy."
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: Data no longer required to meet regulatory requirements.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175576
- Sponsor's protocol ID
- ORTHO.CR.GK9B
- Acronym
- GK9B
- Status last verified
- Feb 2023
- First submitted
- 24 Jun 2014
- Last updated
- 21 Feb 2023
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
- ClinicalTrials.gov ID
- NCT02175576
- Acronym / sponsor ID
- GK9B / ORTHO.CR.GK9B
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Lower Limb Deformity, Post-traumatic Deformity, Complications, Arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data no longer required to meet regulatory requirements.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.
Detailed description
Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanguard XP Bicruciate Knee System | Experimental | Device: Vanguard XP Bicruciate Knee System153 patients receive Vanguard XP Bicruciate Knee System |
| Vanguard CR Knee System | Active comparator | Device: Vanguard CR Knee System153 patients receive Vanguard CR Knee System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- cemented application of components
- bilateral subjects randomized by knee
- patients with pre-existing contralateral knee surgery
- painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
- correction of varus, valgus, or posttraumatic deformity
Key exclusion criteria (17 listed)
- cementless application of components
- BMI greater than or equal to 40
- use of Anterior Stabilized Bearings
- patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees
- correction or revision of previous joint replacement procedure on index knee
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 XP Bicruciate Knee SystemThe Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue. | Device | Vanguard XP Bicruciate Knee System |
| Vanguard CR Knee SystemThe Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design. | Device | Vanguard CR Knee System |
Primary outcome
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)
Time frame: 12 Months
Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.
4 secondary outcomes
Modified Knee Society Score
Time frame: 12 months
Revisions/Removals
Time frame: 3 years
Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)
Time frame: 12 Months
Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- 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.
Hillary Overholser study director
Zimmer Biomet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanguard XP Bicruciate Knee System and Vanguard CR Knee System in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 2 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 6 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: stopped early, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 21 Feb 2023). 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?
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE) (time frame: 12 Months). 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 21 Feb 2023.