Osteoarthritis, KneePhase 4NCT00954954
Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty
A Phase 4 study testing Standard PS RP-MB (P.F.C Sigma Rotating Platform knee) and High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex) in people with Osteoarthritis, Knee, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Standard PS RP-MB (P.F.C Sigma Rotating Platform knee) and High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2006to Jul 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of primary osteoarthritis of knee
- A candidate for total knee replacement arthroplasty
Who cannot join
- A diagnosis other than primary osteoarthritis
- A history of previous open knee surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Department of Orthopaedic Surgery
Seoul, 28, Yongeon-Dong, Jongno-Gu, 110-744
About this study
Official title: Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty: A Prospective Randomized Comparative Study
The aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed with a high-flexion PS RP-MB design would improve range of motion, and that this would be reflected by a better clinical outcome and greater patient satisfaction.
Read the detailed description
A high-flexion, PS RP-MB prosthesis was designed to improve range of motion after total knee arthroplasty without compromising the theoretical advantages of the standard PS RP-MB system. To date, no study has prospectively compared the clinical and radiographic results of standard and high-flexion PS RP-MB designs.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Standard PS RP-MB (P.F.C Sigma Rotating Platform knee), High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)
- Keywords
- Arthroplasty, Replacement, Knee, Range of Motion
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)Device
Also called P.F.C Sigma Rotating Platform knee
Comparison of different types of knee prosthesis
High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)Device
Also called P.F.C Sigma Rotating Platform Flex
Comparison of different types of knee prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses Receives: Device: Standard PS RP-MB (P.F.C Sigma Rotating Platform knee) |
| High-flexion | Active comparator | Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses Receives: Device: High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured.
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 posted7 Aug 2009 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Myung Chul Lee, MD, PhD, Study chair, Seoul National University Hospital Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954954
- Sponsor's protocol ID
- SNUHOSKNEE01-RPRPF
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 7 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT00954954
- Acronym / sponsor ID
- SNUHOSKNEE01-RPRPF
- Conditions
- Osteoarthritis, Knee
- Keywords
- Arthroplasty, Replacement, Knee, Range of Motion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Aug 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 aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed with a high-flexion PS RP-MB design would improve range of motion, and that this would be reflected by a better clinical outcome and greater patient satisfaction.
Detailed description
A high-flexion, PS RP-MB prosthesis was designed to improve range of motion after total knee arthroplasty without compromising the theoretical advantages of the standard PS RP-MB system. To date, no study has prospectively compared the clinical and radiographic results of standard and high-flexion PS RP-MB designs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Device: Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses |
| High-flexion | Active comparator | Device: High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of primary osteoarthritis of knee
- A candidate for total knee replacement arthroplasty
Key exclusion criteria (2 listed)
- A diagnosis other than primary osteoarthritis
- A history of previous open knee 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 |
|---|---|---|
| Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)Also: P.F.C Sigma Rotating Platform kneeComparison of different types of knee prosthesis | Device | Standard |
| High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)Also: P.F.C Sigma Rotating Platform FlexComparison of different types of knee prosthesis | Device | High-flexion |
Primary outcome
Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured.
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 7 Aug 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.
Myung Chul Lee, MD, PhD study chair
Seoul National University Hospital Department 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 Standard PS RP-MB (P.F.C Sigma Rotating Platform knee) and High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex) in people with Osteoarthritis, Knee, run by Seoul National University Hospital 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 2 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: finished, as of the sponsor's last update on 7 Aug 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?
Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured. (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 7 Aug 2009.