OsteoarthritisPhase 2NCT01312532
Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial
A Phase 2 study testing fixed-bearing (P.F.C.® Sigma) and mobile-bearing (P.F.C.® Sigma) in people with Osteoarthritis, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which prosthesis is better in total knee arthroplasty Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- fixed-bearing (P.F.C.® Sigma) and mobile-bearing (P.F.C.® Sigma)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Jun 2004to Nov 2010
- Phase
- Phase 2
- 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
- Patients with expected primary total knee arthroplasty
Who cannot join
- Mediolateral instability
- Infective arthritis
- Severe deformity
- Revision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Prosthesis in Total Knee Arthroplasty
The purpose of this study is to determine which prosthesis is better in total knee arthroplasty
Read the detailed description
Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.
- Conditions
- Osteoarthritis
- Being tested
- fixed-bearing (P.F.C.® Sigma), mobile-bearing (P.F.C.® Sigma)
- Keywords
- Total knee arthroplasty, Fixed-bearing, Mobile-bearing
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixed-bearing (P.F.C.® Sigma)Device
P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK
mobile-bearing (P.F.C.® Sigma)Device
P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK
| Study group | Role | What they receive |
|---|---|---|
| fixed-bearing | Other | fixed-bearing device is a kind of prosthesis Receives: Device: fixed-bearing (P.F.C.® Sigma) |
| mobile-bearing | Other | mobile-bearing device is a kind of prosthesis Receives: Device: mobile-bearing (P.F.C.® Sigma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Scoring
was used for evaluating the function of the knee and high scores indicated better knee function
Measured: five years after surgery
Secondary outcomes (1)
Pain
Pain was evaluated with a Visual Analogue Scale (VAS) with scores ranging from zero to 10ten (0 for no pain and 10 for intolerable pain).
Measured: five years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJun 2004
- Primary completionNov 2010
- Study completionNov 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- mohammad dehghani, A.Professor, Study chair, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312532
- Sponsor's protocol ID
- ASD-1213-17
- Status last verified
- Jun 2004
- First submitted
- 9 Mar 2011
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prosthesis in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01312532
- Acronym / sponsor ID
- ASD-1213-17
- Conditions
- Osteoarthritis
- Keywords
- Total knee arthroplasty, Fixed-bearing, Mobile-bearing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 10 Mar 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 which prosthesis is better in total knee arthroplasty
Detailed description
Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fixed-bearing | Other | Device: fixed-bearing (P.F.C.® Sigma)fixed-bearing device is a kind of prosthesis |
| mobile-bearing | Other | Device: mobile-bearing (P.F.C.® Sigma)mobile-bearing device is a kind of prosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with expected primary total knee arthroplasty
Key exclusion criteria (4 listed)
- Mediolateral instability
- Infective arthritis
- Severe deformity
- Revision
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 |
|---|---|---|
| fixed-bearing (P.F.C.® Sigma)P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK | Device | fixed-bearing |
| mobile-bearing (P.F.C.® Sigma)P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK | Device | mobile-bearing |
Primary outcome
Knee Society Scoring
Time frame: five years after surgery
was used for evaluating the function of the knee and high scores indicated better knee function
1 secondary outcome
Pain
Time frame: five years 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 10 Mar 2011.
- Isfahan university of medical sciencesLink provided by the sponsor.
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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.
mohammad dehghani, A.Professor study chair
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fixed-bearing (P.F.C.® Sigma) and mobile-bearing (P.F.C.® Sigma) in people with Osteoarthritis, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 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: finished, as of the sponsor's last update on 10 Mar 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Scoring (time frame: five years 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 10 Mar 2011.