OsteoarthritisPhase 4CRNCT00916968
Comparison of Function and Fit of Standard and Gender-Specific CR High-Flex Total Knee Prostheses
A Phase 4 study testing Standard CR-Flex total knee and Gender specific CR-Flex in people with Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Standard CR-Flex total knee and Gender specific CR-Flex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2007to May 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.
Who cannot join
- Inflammatory arthritis
- Osteoarthritis effecting hip joint
- Traumatic arthritis
- Neurologic disorders affecting motor function of lower extremity
- foot and ankle disorders limiting ambulation of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Function and Fit of Standard Posterior Cruciate-Retaining High-Flexion and Gender-Specific Posterior Cruciate-Retaining High-Flexion Total Knee Prostheses A Prospective, Randomized Study
The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.
Read the detailed description
The design features of the gender-specific knee prostheses have been claimed to improve fit and function of total knee arthroplasty in women. The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.
- Conditions
- Osteoarthritis
- Being tested
- Standard CR-Flex total knee, Gender specific CR-Flex
- Keywords
- Gender specific, cruciate retaining, total knee arthroplasty, Bilateral Osteoarthritis of the knee joint
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CR-Flex total kneeDevice
Also called Zimmer, Nexgen CR-flex
total knee implant used for joint replacement surgery of the knee
Gender specific CR-FlexDevice
Also called Gender Specific Nexgen CR-Flex implant
TKA by Gender specific Nexgen CR-Flex
| Study group | Role | What they receive |
|---|---|---|
| Standard CR-Flex | Active comparator | Not described Receives: Device: Standard CR-Flex total knee |
| Gender specific CR-Flex | Experimental | Not described Receives: Device: Gender specific CR-Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Knee Score
Measured: 2 years
Secondary outcomes (1)
Implant or bone overhang
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Investigators
- Yoowang Choi, MD, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916968
- Sponsor's protocol ID
- 2009-6-9
- Acronym
- CR
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Function and Fit of Standard Posterior Cruciate-Retaining High-Flexion and Gender-Specific Posterior Cruciate-Retaining High-Flexion Total Knee Prostheses A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT00916968
- Acronym / sponsor ID
- CR / 2009-6-9
- Conditions
- Osteoarthritis
- Keywords
- Gender specific, cruciate retaining, total knee arthroplasty, Bilateral Osteoarthritis of the knee joint
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 10 Jun 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 prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.
Detailed description
The design features of the gender-specific knee prostheses have been claimed to improve fit and function of total knee arthroplasty in women. The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard CR-Flex | Active comparator | Device: Standard CR-Flex total knee |
| Gender specific CR-Flex | Experimental | Device: Gender specific CR-Flex |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.
Key exclusion criteria (5 listed)
- Inflammatory arthritis
- Osteoarthritis effecting hip joint
- Traumatic arthritis
- Neurologic disorders affecting motor function of lower extremity
- foot and ankle disorders limiting ambulation of the patient
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 |
|---|---|---|
| Standard CR-Flex total kneeAlso: Zimmer, Nexgen CR-flextotal knee implant used for joint replacement surgery of the knee | Device | Standard CR-Flex |
| Gender specific CR-FlexAlso: Gender Specific Nexgen CR-Flex implantTKA by Gender specific Nexgen CR-Flex | Device | Gender specific CR-Flex |
Primary outcome
Knee Society Knee Score
Time frame: 2 years
1 secondary outcome
Implant or bone overhang
Time frame: 2 years
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 2 Jul 2009.
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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.
Yoowang Choi, MD principal investigator
Ewha Womans University Mokdong Hospital
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 Standard CR-Flex total knee and Gender specific CR-Flex in people with Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
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 5 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 2 Jul 2009. 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 South Korea. 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?
Knee Society Knee Score (time frame: 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 2 Jul 2009.