Osteoarthritis, KneePhase 4NCT00894361
Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
A Phase 4 study testing TKA surgery with the rotating platform mobile-bearing knee design and TKA surgery with the all-polyethylene tibia knee design in people with Osteoarthritis, Knee, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee… 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 the rotating platform mobile-bearing knee design and TKA surgery with the all-polyethylene tibia knee design
- Type of treatment
- 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
- Oct 2001to Jan 2007
- Phase
- Phase 4
- 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 primary total knee arthroplasty
Who cannot join
- substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
- patients whose mental function precluded them from responding to our standard questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs
This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:
- Does a RP design offer improvement in range of motion over a AP design?
- Does a RP design have improved wear characteristics over a nonmodular AP design?
- Is there a clear clinical advantage to the RP design that justifies its increased cost?
Read more
Answering these questions will allow surgeons to use RP designs appropriately in different demand populations.
This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.
- Conditions
- Osteoarthritis, Knee
- Being tested
- TKA surgery with the rotating platform mobile-bearing knee design, TKA surgery with the all-polyethylene tibia knee design
- Keywords
- knee arthritis, total knee arthroplasty, total knee replacement, mobile bearing design, all-polyethylene tibia
- 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 the rotating platform mobile-bearing knee designProcedure or surgery
Depuy Sigma RP rotating platform design
TKA surgery with the all-polyethylene tibia knee designProcedure or surgery
Depuy Sigma fixed-bearing design with all-polyethylene tibia
| Study group | Role | What they receive |
|---|---|---|
| rotating-platform design TKA | Active comparator | patients who were randomized to receive the rotating platform mobile-bearing TKA design Receives: Procedure: TKA surgery with the rotating platform mobile-bearing knee design |
| all-polyethylene tibia design TKA | Active comparator | patients who were randomized to receive the all-polyethylene tibial component design Receives: Procedure: TKA surgery with the all-polyethylene tibia knee design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Postoperative Range of Motion (ROM) at 2 Years
range of motion of the knee postoperatively at 2 years
Measured: 2 years
Secondary outcomes (1)
Survival of the Implants to Subject Death or Implant Removal
Measured: 10 or more years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startOct 2001
- Primary completionJan 2007
- Study completionJan 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- 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, Dept. of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894361
- Sponsor's protocol ID
- MVA-3028
- Status last verified
- Sep 2020
- First submitted
- 24 Mar 2009
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gioe TJ, Glynn J, Sembrano J, Suthers K, Santos ER, Singh J. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs. A prospective randomized trial. J Bone Joint Surg Am. 2009 Sep;91(9):2104-12. doi: 10.2106/JBJS.H.01442.
PubMed 19723986
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 Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs
- ClinicalTrials.gov ID
- NCT00894361
- Acronym / sponsor ID
- MVA-3028
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee arthritis, total knee arthroplasty, total knee replacement, mobile bearing design, all-polyethylene tibia
- Phase
- Phase 4
- 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
- Oct 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Posted 7 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:
- Does a RP design offer improvement in range of motion over a AP design?
- Does a RP design have improved wear characteristics over a nonmodular AP design?
- Is there a clear clinical advantage to the RP design that justifies its increased cost?
Answering these questions will allow surgeons to use RP designs appropriately in different demand populations.
This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rotating-platform design TKA | Active comparator | Procedure: TKA surgery with the rotating platform mobile-bearing knee designpatients who were randomized to receive the rotating platform mobile-bearing TKA design |
| all-polyethylene tibia design TKA | Active comparator | Procedure: TKA surgery with the all-polyethylene tibia knee designpatients who were randomized to receive the all-polyethylene tibial component 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 primary total knee arthroplasty
Key exclusion criteria (2 listed)
- substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
- patients whose mental function precluded 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 the rotating platform mobile-bearing knee designDepuy Sigma RP rotating platform design | Procedure or surgery | rotating-platform design TKA |
| TKA surgery with the all-polyethylene tibia knee designDepuy Sigma fixed-bearing design with all-polyethylene tibia | Procedure or surgery | all-polyethylene tibia design TKA |
Primary outcome
Knee Postoperative Range of Motion (ROM) at 2 Years
Time frame: 2 years
range of motion of the knee postoperatively at 2 years
1 secondary outcome
Survival of the Implants to Subject Death or Implant Removal
Time frame: 10 or more 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.
- Results publication: PubMed 19723986Gioe TJ, Glynn J, Sembrano J, Suthers K, Santos ER, Singh J. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs. A prospective randomized trial. J Bone Joint Surg Am. 2009 Sep;91(9):2104-12. doi: 10.2106/JBJS.H.01442.
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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.
Terence J Gioe, M.D. principal investigator
Minneapolis VAMC, Dept. of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TKA surgery with the rotating platform mobile-bearing knee design and TKA surgery with the all-polyethylene tibia knee design 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 2 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.
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?
Yes. Results are posted in the registry (first posted 7 May 2009). 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?
Knee Postoperative Range of Motion (ROM) at 2 Years (time frame: 2 years). 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 NCT00894361, 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 7 Sep 2020.