OsteoarthritisPhase 4NCT01335438
Total Knee Arthroplasty Comparing Cementless to Cemented Fixation
A Phase 4 study testing Cementless (Nexgen) and Cemented (Nexgen) in people with Osteoarthritis, run by Young Hoo Kim at 1 site in South Korea.
Trial summary
The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Cementless (Nexgen) and Cemented (Nexgen)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 1997to 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
Who cannot join
- Inflammatory disease
- patient with other Lower extremity disease which may affect functional outcome
- Neurologic disease effecting patients lower extremity
- Revision surgery
- Patient not medically cleared for bilateral surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Knee Arthroplasty Comparing Cementless to Cemented Fixation, A Prospective Comparison of Long Term Outcomes Using and Identical Design of Prosthesis
The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.
Read the detailed description
Out comes measures were to determine:
- whether the knee and function scores and the radiographic results of the knees with a Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis.
- whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis.
- whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis
- whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless prosthesis.
- Conditions
- Osteoarthritis
- Being tested
- Cementless (Nexgen), Cemented (Nexgen)
- Keywords
- total knee arthroplasty, cemented, cementless, fixation, posterior stabilized, cruciate retaining
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cementless (Nexgen)Device
Also called Cementless Nexgen
Cementless fixation of Nexgen CR TKR
Cemented (Nexgen)Device
Also called Cemented Nexgen
Cemented fixation of Nexgen CR TKR
| Study group | Role | What they receive |
|---|---|---|
| Cementless Nexgen CR | Experimental | Cementless fixation of Nexgen CR TKR Receives: Device: Cementless (Nexgen) |
| Cemented Nexgen CR | Active comparator | Cemented fixation of Nexgen CR TKR Receives: Device: Cemented (Nexgen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Knee Society Knee Score
change in knee score will be compared with initial score, until mean follow up of 25 years.
Measured: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
Secondary outcomes (1)
Improvement in the Range of Motion
change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 25 years.
Measured: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startJan 1997
- Primary completionFeb 1998
- Study completionMar 2011
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Young Hoo Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Young Hoo Kim, Ewha Womans University
- Investigators
- Jang Won Park, MD, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335438
- Sponsor's protocol ID
- TKRcementless
- Status last verified
- Oct 2011
- First submitted
- 11 Apr 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty Comparing Cementless to Cemented Fixation, A Prospective Comparison of Long Term Outcomes Using and Identical Design of Prosthesis
- ClinicalTrials.gov ID
- NCT01335438
- Acronym / sponsor ID
- TKRcementless
- Conditions
- Osteoarthritis
- Keywords
- total knee arthroplasty, cemented, cementless, fixation, posterior stabilized, cruciate retaining
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Young Hoo KimUniversity, hospital or other
- Study start
- Jan 1997
- Primary completion
- Feb 1998 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 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 purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.
Detailed description
Out comes measures were to determine:
- whether the knee and function scores and the radiographic results of the knees with a Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis.
- whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis.
- whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis
- whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cementless Nexgen CR | Experimental | Device: Cementless (Nexgen)Cementless fixation of Nexgen CR TKR |
| Cemented Nexgen CR | Active comparator | Device: Cemented (Nexgen)Cemented fixation of Nexgen CR TKR |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
Key exclusion criteria (5 listed)
- Inflammatory disease
- patient with other Lower extremity disease which may affect functional outcome
- Neurologic disease effecting patients lower extremity
- Revision surgery
- Patient not medically cleared for bilateral surgery
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 |
|---|---|---|
| Cementless (Nexgen)Also: Cementless NexgenCementless fixation of Nexgen CR TKR | Device | Cementless Nexgen CR |
| Cemented (Nexgen)Also: Cemented NexgenCemented fixation of Nexgen CR TKR | Device | Cemented Nexgen CR |
Primary outcome
Improvement in Knee Society Knee Score
Time frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
change in knee score will be compared with initial score, until mean follow up of 25 years.
1 secondary outcome
Improvement in the Range of Motion
Time frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
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 5 Oct 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.
Jang Won Park, 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 Cementless (Nexgen) and Cemented (Nexgen) in people with Osteoarthritis, run by Young Hoo Kim 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 5 Oct 2011. 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?
Improvement in Knee Society Knee Score (time frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery). 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 5 Oct 2011.