Osteoarthritis, KneeNCT00979147
Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty
A study testing TKA surgery with modular polished tibial baseplate/XLK design, TKA surgery with the nonmodular APT/GVF design and P.F.C.® Sigma Knee System in people with Osteoarthritis, Knee, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
This study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- TKA surgery with modular polished tibial baseplate/XLK design, TKA surgery with the nonmodular APT/GVF design and P.F.C.® Sigma Knee System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Nov 2013
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally accepted clinical and radiographic criteria for total knee arthroplasty
Who cannot join
- Significant angular or bony deformity necessitating structural bone grafting or more extensive modular designs will be excluded at the discretion of the principle investigator
- Routine contraindications to TKA (active sepsis, Charcot arthropathy)
- Patients whose mental function preclude them from responding to our standard questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Prospective Level 1 Comparison of a Modular Polished Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty
This study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Comparing these two designs will afford us information in the following areas:
- Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design?
- Is there a clear clinical advantage to the MPT/XLK design in certain patient populations that justify its use over the APT/GVF design?
Read more
Answering these questions will allow surgeons to use both designs appropriately in different demand populations.
This study is designed to address the questions of whether an MPT/XLK design offers improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic measures, over an APT design. The investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.
Read the detailed description
Summary is detailed
- Conditions
- Osteoarthritis, Knee
- Being tested
- TKA surgery with modular polished tibial baseplate/XLK design, TKA surgery with the nonmodular APT/GVF design, P.F.C.® Sigma Knee System
- Keywords
- knee arthritis, total knee arthroplasty, total knee replacement, metal backed tibial component, all-polyethylene tibia, modular polished tibial baseplate
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKA surgery with modular polished tibial baseplate/XLK designProcedure or surgery
Also called P.F.C.® Sigma Knee System with modular XLK poly
TKA surgery with modular polished tibial baseplate/XLK design
TKA surgery with the nonmodular APT/GVF designProcedure or surgery
Also called P.F.C. ® Sigma Knee with an all-poly GVF tibia
TKA surgery with the nonmodular APT/GVF design
P.F.C.® Sigma Knee SystemDevice
P.F.C.® Sigma Knee System with modular XLK poly
P.F.C.® Sigma Knee SystemDevice
P.F.C. ® Sigma Knee System with an all-poly GVF tibia
| Study group | Role | What they receive |
|---|---|---|
| Modular Metal Tibial Baseplate | Experimental | Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA Receives: Procedure: TKA surgery with modular polished tibial baseplate/XLK design; Device: P.F.C.® Sigma Knee System |
| All Polyethylene Tibial Baseplate | Active comparator | Patients who were randomized to receive the nonmodular APT/GVF TKA design. Receives: Procedure: TKA surgery with the nonmodular APT/GVF design; Device: P.F.C.® Sigma Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)
Patient recorded outcome measures as noted
Measured: 2 year follow-up intervals up to 20 years
Secondary outcomes (1)
Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene
Wear characteristics as above
Measured: 2 year followup intervals to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionMay 2013
- Study completionNov 2013
Why it stopped: PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
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 Osteoarthritis, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Depuy, Inc.
- Responsible party
- Principal investigator, Terence J. Gioe, M.D., Minneapolis Veterans Affairs Medical Center
- Investigators
- Terence J Gioe, M.D., Principal investigator, Minneapolis VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979147
- Sponsor's protocol ID
- MVA-3946B
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2009
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Level 1 Comparison of a Modular Polished Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00979147
- Acronym / sponsor ID
- MVA-3946B
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee arthritis, total knee arthroplasty, total knee replacement, metal backed tibial component, all-polyethylene tibia, modular polished tibial baseplate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Depuy, Inc.
- Study start
- Nov 2007
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Posted 7 Sep 2020
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 designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Comparing these two designs will afford us information in the following areas:
- Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design?
- Is there a clear clinical advantage to the MPT/XLK design in certain patient populations that justify its use over the APT/GVF design?
Answering these questions will allow surgeons to use both designs appropriately in different demand populations.
This study is designed to address the questions of whether an MPT/XLK design offers improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic measures, over an APT design. The investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.
Detailed description
Summary is detailed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modular Metal Tibial Baseplate | Experimental | Procedure: TKA surgery with modular polished tibial baseplate/XLK design, Device: P.F.C.® Sigma Knee SystemPatients who were randomized to receive the modular polished tibial baseplate/XLK TKA |
| All Polyethylene Tibial Baseplate | Active comparator | Procedure: TKA surgery with the nonmodular APT/GVF design, Device: P.F.C.® Sigma Knee SystemPatients who were randomized to receive the nonmodular APT/GVF TKA design. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- generally accepted clinical and radiographic criteria for total knee arthroplasty
Key exclusion criteria (3 listed)
- Significant angular or bony deformity necessitating structural bone grafting or more extensive modular designs will be excluded at the discretion of the principle investigator
- Routine contraindications to TKA (active sepsis, Charcot arthropathy)
- Patients whose mental function preclude them from responding to our standard questionnaires
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 |
|---|---|---|
| TKA surgery with modular polished tibial baseplate/XLK designAlso: P.F.C.® Sigma Knee System with modular XLK polyTKA surgery with modular polished tibial baseplate/XLK design | Procedure or surgery | Modular Metal Tibial Baseplate |
| TKA surgery with the nonmodular APT/GVF designAlso: P.F.C. ® Sigma Knee with an all-poly GVF tibiaTKA surgery with the nonmodular APT/GVF design | Procedure or surgery | All Polyethylene Tibial Baseplate |
| P.F.C.® Sigma Knee SystemP.F.C.® Sigma Knee System with modular XLK poly | Device | Modular Metal Tibial Baseplate |
| P.F.C.® Sigma Knee SystemP.F.C. ® Sigma Knee System with an all-poly GVF tibia | Device | All Polyethylene Tibial Baseplate |
Primary outcome
Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)
Time frame: 2 year follow-up intervals up to 20 years
Patient recorded outcome measures as noted
1 secondary outcome
Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene
Time frame: 2 year followup intervals to 20 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Terence J Gioe, M.D. principal investigator
Minneapolis VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TKA surgery with modular polished tibial baseplate/XLK design, TKA surgery with the nonmodular APT/GVF design and P.F.C.® Sigma Knee System in people with Osteoarthritis, Knee, run by Minneapolis Veterans Affairs Medical Center 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 1 inclusion and 3 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 7 Sep 2020. 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?
Yes. Results are posted in the registry (first posted 7 Sep 2020). 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?
Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36) (time frame: 2 year follow-up intervals up to 20 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 7 Sep 2020.