Knee OsteoarthritisNCT01659229
Fluoroscopic Analysis of PFC CR 150 Versus Standard PFC CR Total Knee Arthroplasty Implants in Deep Flexion
An observational study of Knee Osteoarthritis, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear… Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2011to Dec 2012
- Phase
- Observational
- 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant
Who may be able to join
- All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant
- Surgery more than 2 years
- Able to walk, climb stairs
Who cannot join
- Knee stiffness with less than 100 degrees of knee range of movement
- Patients who required revision surgery
- Patients who received an all polyethylene tibial insert
- Patients who received rotating platform tibial tray
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants
The investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear resistance. It can accommodate up to 150 degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which can accommodate up to 120 degrees of flexion.
Read the detailed description
Both sets of patients will undergo routine post-operative follow up in clinic. The study involves patients who had their surgery more than 2 years ago. We assess their range of movement using fluoroscopy. They are asked to perform lunges, squats and climbing up and down 3 steps. The fluoroscopic images are then analysed to assess their individual range of movements.
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PFC CR 150 total knee implant | Study group implant: PFC CR 150 Control group implant: PFC CR standard | |
| PFC CR Standard | study group implant: PFC CR 150 control group implant: PFC CR Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexion-extension range of movement of operated knee
Fluoroscopic studies are done as patient perform lunges, squats and climb up and down stairs.
Measured: 2 years after their total knee replacement surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Singapore General 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International
- Responsible party
- Sponsor
- Investigators
- Dr Seng Jin Yeo, MBBS FRCS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659229
- Sponsor's protocol ID
- 63214040
- Status last verified
- Aug 2012
- First submitted
- 3 Aug 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Nicholls RL, Schirm AC, Jeffcote BO, Kuster MS. Tibiofemoral force following total knee arthroplasty: comparison of four prosthesis designs in vitro. J Orthop Res. 2007 Nov;25(11):1506-12. doi: 10.1002/jor.20438.
PubMed 17568418
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants
- ClinicalTrials.gov ID
- NCT01659229
- Acronym / sponsor ID
- 63214040
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- DePuy International
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Aug 2012 (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 investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear resistance. It can accommodate up to 150 degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which can accommodate up to 120 degrees of flexion.
Detailed description
Both sets of patients will undergo routine post-operative follow up in clinic. The study involves patients who had their surgery more than 2 years ago. We assess their range of movement using fluoroscopy. They are asked to perform lunges, squats and climbing up and down 3 steps. The fluoroscopic images are then analysed to assess their individual range of movements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFC CR 150 total knee implant | – | –Study group implant: PFC CR 150 Control group implant: PFC CR standard |
| PFC CR Standard | – | –study group implant: PFC CR 150 control group implant: PFC CR Standard |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant
Key inclusion criteria (3 listed)
- All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant
- Surgery more than 2 years
- Able to walk, climb stairs
Key exclusion criteria (4 listed)
- Knee stiffness with less than 100 degrees of knee range of movement
- Patients who required revision surgery
- Patients who received an all polyethylene tibial insert
- Patients who received rotating platform tibial tray
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flexion-extension range of movement of operated knee
Time frame: 2 years after their total knee replacement surgery
Fluoroscopic studies are done as patient perform lunges, squats and climb up and down stairs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Background: PubMed 17568418Nicholls RL, Schirm AC, Jeffcote BO, Kuster MS. Tibiofemoral force following total knee arthroplasty: comparison of four prosthesis designs in vitro. J Orthop Res. 2007 Nov;25(11):1506-12. doi: 10.1002/jor.20438.
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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.
Dr Seng Jin Yeo, MBBS FRCS principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Singapore General Hospital at 1 site in Singapore.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Aug 2012. 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 Singapore. 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.
Are results available for this study?
Results are not available in the source record.
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?
Flexion-extension range of movement of operated knee (time frame: 2 years after their total knee replacement surgery). 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 NCT01659229, 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 20 Aug 2012.