Osteoarthritis of the KneePhase 4Bake-OffNCT01331278
A Comparative Study of Knee Systems
A Phase 4 study testing Total Knee Arthroplasty with Custom Cutting Blocks and Total Knee Arthroplasty via Computer Assisted Surgery in people with Osteoarthritis of the Knee, run by Foundation for Southwest Orthopedic Research at 2 sites in United States.
Trial summary
The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Total Knee Arthroplasty with Custom Cutting Blocks and Total Knee Arthroplasty via Computer Assisted Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Mar 2011
- Phase
- Phase 4
- 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
Who may be able to join
- must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date
- must be 18 years of age or older
- must be capable and willing to provide informed consent
- must have flexion contracture less than 15 degrees.
- must have ligament stability no more than 2 degrees instability in varus/valgus extension stress
Who cannot join
- medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op
- currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
- known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
- Knee alignment deformities greater than 7 degrees varus or valgus
- known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
- known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southwest Orthopedic Group, LLP
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty
The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Total Knee Arthroplasty with Custom Cutting Blocks, Total Knee Arthroplasty via Computer Assisted Surgery
- Keywords
- total joint replacement, knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Arthroplasty with Custom Cutting BlocksProcedure or surgery
Also called Signature Knee System
Subjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant
Total Knee Arthroplasty via Computer Assisted SurgeryProcedure or surgery
Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant
| Study group | Role | What they receive |
|---|---|---|
| Custom Cutting Blocks | Active comparator | Not described Receives: Procedure: Total Knee Arthroplasty with Custom Cutting Blocks |
| Computer Assisted Surgery | Active comparator | Not described Receives: Procedure: Total Knee Arthroplasty via Computer Assisted Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean intraoperative time
Time measured in pre-defined segments from the point that the patient is wheeled into the OR until the OR is clean and ready for the next case's activities to begin.
Measured: measured during surgery (day 1)
Secondary outcomes (1)
alignment accuracy
Measured: 3 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Southwest Orthopedic Research
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331278
- Sponsor's protocol ID
- 0509-0060
- Acronym
- Bake-Off
- Status last verified
- Apr 2011
- First submitted
- 6 Apr 2011
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lionberger DR, Crocker CL, Chen V. Patient specific instrumentation. J Arthroplasty. 2014 Sep;29(9):1699-704. doi: 10.1016/j.arth.2014.03.019. Epub 2014 Mar 28.
PubMed 24810539
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01331278
- Acronym / sponsor ID
- Bake-Off / 0509-0060
- Conditions
- Osteoarthritis of the Knee
- Keywords
- total joint replacement, knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Foundation for Southwest Orthopedic ResearchUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Apr 2011 (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 custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom Cutting Blocks | Active comparator | Procedure: Total Knee Arthroplasty with Custom Cutting Blocks |
| Computer Assisted Surgery | Active comparator | Procedure: Total Knee Arthroplasty via Computer Assisted Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date
- must be 18 years of age or older
- must be capable and willing to provide informed consent
- must have flexion contracture less than 15 degrees.
- must have ligament stability no more than 2 degrees instability in varus/valgus extension stress
Key exclusion criteria (6 listed)
- medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op
- currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
- known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
- Knee alignment deformities greater than 7 degrees varus or valgus
- known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
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 |
|---|---|---|
| Total Knee Arthroplasty with Custom Cutting BlocksAlso: Signature Knee SystemSubjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant | Procedure or surgery | Custom Cutting Blocks |
| Total Knee Arthroplasty via Computer Assisted SurgerySubjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant | Procedure or surgery | Computer Assisted Surgery |
Primary outcome
mean intraoperative time
Time frame: measured during surgery (day 1)
Time measured in pre-defined segments from the point that the patient is wheeled into the OR until the OR is clean and ready for the next case's activities to begin.
1 secondary outcome
alignment accuracy
Time frame: 3 weeks post-op
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 8 Apr 2011.
- Derived from this study: PubMed 24810539Lionberger DR, Crocker CL, Chen V. Patient specific instrumentation. J Arthroplasty. 2014 Sep;29(9):1699-704. doi: 10.1016/j.arth.2014.03.019. Epub 2014 Mar 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Total Knee Arthroplasty with Custom Cutting Blocks and Total Knee Arthroplasty via Computer Assisted Surgery in people with Osteoarthritis of the Knee, run by Foundation for Southwest Orthopedic Research 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 5 inclusion and 6 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 8 Apr 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
mean intraoperative time (time frame: measured during surgery (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331278, which also lists 1 linked publication.
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 8 Apr 2011.