Osteoarthritis of the KneeCutting BlockNCT01072019
A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides
A study testing Instrument in people with Osteoarthritis of the Knee, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery: 1. Standard knee cutting guides; 2. MRI generated patient specific custom cutting guides. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Instrument
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2014
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 75
- Diagnosis of osteoarthritis of the knee and qualify for surgery, as indicated by one of the following:
- Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
- Correction of varus or valgus.
- Willing to participate and return for follow-up study visits.
Who cannot join
- Infection
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
Show all 21Show fewer
- 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
- Previous osteotomy
- Diagnosis of rheumatoid arthritis
- Previous patella fracture or surgery
- Previous healed tibia or femur fractures
- Previous joint replacement surgery
- Cannot have an MRI
- Patients receiving single-stage bilateral total knee arthroplasty (TKA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques
The purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery:
- Standard knee cutting guides;
- MRI generated patient specific custom cutting guides.
Both types of cutting guides used in this study are registered with the U.S. Food and Drug Administration (FDA) and are routinely used for knee replacement surgery. However, it is unknown if one type of cutting guide has risks or benefits over the other.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Instrument
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InstrumentOther
Also called Vanguard® Knee System, Signature™ Custom Guides
Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.
| Study group | Role | What they receive |
|---|---|---|
| Standard knee cutting guides | Active comparator | Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod. Receives: Other: Instrument |
| MRI generated patient specific custom cutting guides | Active comparator | Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone. Receives: Other: Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient dissatisfaction following primary total knee replacement.
Measured: Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively.
Secondary outcomes (1)
Postoperative recovery time following primary total knee replacement.
Measured: Immediate postoperative period (prior to discharge) and at four to six weeks, three months, six months, and one year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Ryan M Nunley, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072019
- Sponsor's protocol ID
- 10-0018
- Other IDs
- Ortho.CR.K018.10
- Acronym
- Cutting Block
- Status last verified
- Jun 2018
- First submitted
- 18 Feb 2010
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques
- ClinicalTrials.gov ID
- NCT01072019
- Acronym / sponsor ID
- Cutting Block / 10-0018
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Mar 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Feb 2010 (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 study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery:
- Standard knee cutting guides;
- MRI generated patient specific custom cutting guides.
Both types of cutting guides used in this study are registered with the U.S. Food and Drug Administration (FDA) and are routinely used for knee replacement surgery. However, it is unknown if one type of cutting guide has risks or benefits over the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard knee cutting guides | Active comparator | Other: InstrumentStandard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod. |
| MRI generated patient specific custom cutting guides | Active comparator | Other: InstrumentPatient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 75
- Diagnosis of osteoarthritis of the knee and qualify for surgery, as indicated by one of the following:
- Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
- Correction of varus or valgus.
- Willing to participate and return for follow-up study visits.
Key exclusion criteria (21 listed)
- Infection
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Osteoporosis
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 |
|---|---|---|
| InstrumentAlso: Vanguard® Knee System, Signature™ Custom GuidesRandomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides. | Other | MRI generated patient specific custom cutting guides, Standard knee cutting guides |
Primary outcome
Patient dissatisfaction following primary total knee replacement.
Time frame: Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively.
1 secondary outcome
Postoperative recovery time following primary total knee replacement.
Time frame: Immediate postoperative period (prior to discharge) and at four to six weeks, three months, six months, and one year postoperatively.
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 27 Jun 2018.
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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.
Ryan M Nunley, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument in people with Osteoarthritis of the Knee, run by Washington University School of Medicine at 1 site 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 5 inclusion and 21 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 27 Jun 2018. 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 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?
Patient dissatisfaction following primary total knee replacement. (time frame: Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively.). 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 27 Jun 2018.