Osteoarthritis, KneePhase 4NCT00375856
Computer-Assisted Total Knee Replacement Kinematics: DePuy Sigma Posterior Cruciate Substituting Knee and the DePuy Sigma RP Rotating Platform Knee
A Phase 4 study testing DePuy P.F.C.® Sigma Rotating Platform Knee in people with Osteoarthritis, Knee, run by Queen's University at 3 sites in Canada.
Trial summary
Primary Research Questions: 1. Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- DePuy P.F.C.® Sigma Rotating Platform Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2006to Dec 2012
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-75 years
- Undergoing primary total knee arthroplasty
- Clinically significant osteoarthritic degeneration
Who cannot join
- Active articular infections
- Bilateral knee replacement (simultaneous)
- Previous joint infections
- Significant concurrent ipsilateral hip osteoarthritis
- Chronic pain syndrome requiring medications for control
- History of chemical addiction
Show all 15Show fewer
- Significant spinal stenosis, significant symptomatic sciatica
- Patients who are unlikely to comply with, participate in, or return for follow-up visits as described in the protocol
- Osteomyelitis, septicemia or other infections that may spread to other areas of the body
- Highly communicable diseases, immuno-compromising conditions and/or conditions that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease)
- Decreased mental comprehension and literacy
- Prior high tibial osteotomy
- Prior patellectomy
- Rheumatoid arthritis
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Kingston General Hospital
Kingston, Ontario
London Health Sciences Center
London, Ontario, N6A 5A5
University of Manitoba
Winnipeg, Manitoba, R2K 3S8
About this study
Official title: An Investigation of Computer-Assisted Total Knee Replacement Kinematics on Patient Performance: An Examination of the DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee and the DePuy P.F.C.® Sigma RP Rotating Platform Knee Systems
Primary Research Questions:
- Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e. quality of life, function, range of motion) than similar patients who undergo total knee arthroplasty (TKA) using the Sigma fixed bearing knee?
- Do patients with knee OA who undergo TKA with a Sigma rotating platform have different knee kinetics and kinematics as measured by gait analysis than similar patients who undergo TKA using the Sigma fixed bearing knee?
- Do patients with knee OA who undergo TKA with or without computer assistance have better clinical outcomes at two years following surgery (quality of life, function, range of motion)?
- Do patients with knee OA who undergo TKA with or without computer assistance have different knee kinematics and kinetics as measured by gait analysis?
- Conditions
- Osteoarthritis, Knee
- Being tested
- DePuy P.F.C.® Sigma Rotating Platform Knee
- Keywords
- arthroplasty, knee, computer-assist, gait, Total knee arthroplasty, knee prostheses
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy P.F.C.® Sigma Rotating Platform KneeDevice
Also called no other name
no details
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee |
| 2 | Experimental | Rotating Platform Knee Receives: Device: DePuy P.F.C.® Sigma Rotating Platform Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait and radiographic parameters
Measured: 0
Secondary outcomes (1)
Knee pain, function
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Principal investigator, Dr. John Rudan, Queen's University
- Investigators
- John F Rudan, MD, Principal investigator, Queen's University/Kingston General HospitalSteve MacDonald, MD, Principal investigator, London Health Sciences CenterEric Bohm, MD, Principal investigator, University of Manitoba/Concordia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375856
- Sponsor's protocol ID
- DepuyRP06
- Status last verified
- May 2013
- First submitted
- 12 Sep 2006
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Computer-Assisted Total Knee Replacement Kinematics on Patient Performance: An Examination of the DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee and the DePuy P.F.C.® Sigma RP Rotating Platform Knee Systems
- ClinicalTrials.gov ID
- NCT00375856
- Acronym / sponsor ID
- DepuyRP06
- Conditions
- Osteoarthritis, Knee
- Keywords
- arthroplasty, knee, computer-assist, gait, Total knee arthroplasty, knee prostheses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Oct 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Sep 2006 (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.
Primary Research Questions:
- Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e. quality of life, function, range of motion) than similar patients who undergo total knee arthroplasty (TKA) using the Sigma fixed bearing knee?
- Do patients with knee OA who undergo TKA with a Sigma rotating platform have different knee kinetics and kinematics as measured by gait analysis than similar patients who undergo TKA using the Sigma fixed bearing knee?
- Do patients with knee OA who undergo TKA with or without computer assistance have better clinical outcomes at two years following surgery (quality of life, function, range of motion)?
- Do patients with knee OA who undergo TKA with or without computer assistance have different knee kinematics and kinetics as measured by gait analysis?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee |
| 2 | Experimental | Device: DePuy P.F.C.® Sigma Rotating Platform KneeRotating Platform Knee |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 45-75 years
- Undergoing primary total knee arthroplasty
- Clinically significant osteoarthritic degeneration
Key exclusion criteria (15 listed)
- Active articular infections
- Bilateral knee replacement (simultaneous)
- Previous joint infections
- Significant concurrent ipsilateral hip osteoarthritis
- Chronic pain syndrome requiring medications for control
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 |
|---|---|---|
| DePuy P.F.C.® Sigma Rotating Platform KneeAlso: no other nameno details | Device | 2 |
Primary outcome
Gait and radiographic parameters
Time frame: 0
1 secondary outcome
Knee pain, function
Time frame: 0
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 27 Sep 2016.
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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.
John F Rudan, MD principal investigator
Queen's University/Kingston General Hospital
Steve MacDonald, MD principal investigator
London Health Sciences Center
Eric Bohm, MD principal investigator
University of Manitoba/Concordia Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DePuy P.F.C.® Sigma Rotating Platform Knee in people with Osteoarthritis, Knee, run by Queen's University at 3 sites in Canada.
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 15 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Gait and radiographic parameters (time frame: 0). 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 27 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.