Knee OsteoarthritisNCT00937170
Study Comparing Traditional and Gender-specific Total Knee Replacement Designs
A study testing Zimmer LPS flex Gender Specific Implant (Total knee replacement), Zimmer High Flex LPS Implant (Total knee replacement) and Stryker Triathlon Implant (Total knee replacement) in people with Knee Osteoarthritis, run by UConn Health.
Trial summary
The purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Zimmer LPS flex Gender Specific Implant (Total knee replacement), Zimmer High Flex LPS Implant (Total knee replacement) and Stryker Triathlon Implant (Total knee replacement)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2009
- 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 40 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of end-stage degenerative joint disease of the knee
- must be deemed appropriate for total knee replacement surgery
Who cannot join
- severe flexion deformity of the knee
- greater than 20deg varus or valgus malalignment
- osteomyelitis, septicemia, prior infection of the knee joint
- presence of infections or highly communicable diseases
- significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity
- metastatic disease
Show all 9Show fewer
- congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success
- previous total knee replacement in affected knee
- arthrodesis of the affected knee
About this study
Official title: A Prospective, Randomized, Control Trial Comparing Total Knee Arthroplasty With Traditional and Gender-Specific Designs
The purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.
- Conditions
- Knee Osteoarthritis
- Being tested
- Zimmer LPS flex Gender Specific Implant (Total knee replacement), Zimmer High Flex LPS Implant (Total knee replacement), Stryker Triathlon Implant (Total knee replacement)
- Keywords
- Total Knee Replacement, Gender Specific Design
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer LPS flex Gender Specific Implant (Total knee replacement)Device
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
Zimmer High Flex LPS Implant (Total knee replacement)Device
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
Stryker Triathlon Implant (Total knee replacement)Device
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
| Study group | Role | What they receive |
|---|---|---|
| Gender Specific LPS flex | Experimental | Participants in this arm will receive the Zimmer LPS flex Gender Specific Implant design Receives: Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement) |
| LPS flex | Active comparator | Participants in this arm will receive the Zimmer High Flex LPS implant Receives: Device: Zimmer High Flex LPS Implant (Total knee replacement) |
| Triathlon | Active comparator | Participants in this arm will receive the Stryker Triathlon Implant design Receives: Device: Stryker Triathlon Implant (Total knee replacement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of improved pain relief and function
Measured: Pre-op, 4 weeks, 4 months, 1 year, 2 years
Secondary outcomes (1)
Evidence of improved patellofemoral biomechanics
Measured: Pre-op, 4 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Investigators
- R. Michael Meneghini, M.D., Principal investigator, University of Connecticut Health Center, Farmington CT, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937170
- Sponsor's protocol ID
- 09-036C-2
- Other IDs
- RMM001
- Status last verified
- Jan 2011
- First submitted
- 9 Jul 2009
- Last updated
- 21 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Control Trial Comparing Total Knee Arthroplasty With Traditional and Gender-Specific Designs
- ClinicalTrials.gov ID
- NCT00937170
- Acronym / sponsor ID
- 09-036C-2
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Knee Replacement, Gender Specific Design
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 10 Jul 2009 (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 compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gender Specific LPS flex | Experimental | Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement)Participants in this arm will receive the Zimmer LPS flex Gender Specific Implant design |
| LPS flex | Active comparator | Device: Zimmer High Flex LPS Implant (Total knee replacement)Participants in this arm will receive the Zimmer High Flex LPS implant |
| Triathlon | Active comparator | Device: Stryker Triathlon Implant (Total knee replacement)Participants in this arm will receive the Stryker Triathlon Implant design |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of end-stage degenerative joint disease of the knee
- must be deemed appropriate for total knee replacement surgery
Key exclusion criteria (9 listed)
- severe flexion deformity of the knee
- greater than 20deg varus or valgus malalignment
- osteomyelitis, septicemia, prior infection of the knee joint
- presence of infections or highly communicable diseases
- significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity
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 |
|---|---|---|
| Zimmer LPS flex Gender Specific Implant (Total knee replacement)Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company | Device | Gender Specific LPS flex |
| Zimmer High Flex LPS Implant (Total knee replacement)Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company | Device | LPS flex |
| Stryker Triathlon Implant (Total knee replacement)Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company | Device | Triathlon |
Primary outcome
Evidence of improved pain relief and function
Time frame: Pre-op, 4 weeks, 4 months, 1 year, 2 years
1 secondary outcome
Evidence of improved patellofemoral biomechanics
Time frame: Pre-op, 4 months, 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2011.
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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.
R. Michael Meneghini, M.D. principal investigator
University of Connecticut Health Center, Farmington CT, United States
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer LPS flex Gender Specific Implant (Total knee replacement), Zimmer High Flex LPS Implant (Total knee replacement) and Stryker Triathlon Implant (Total knee replacement) in people with Knee Osteoarthritis, run by UConn Health.
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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 21 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evidence of improved pain relief and function (time frame: Pre-op, 4 weeks, 4 months, 1 year, 2 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 21 Jan 2011.