OsteoarthritisNCT02319291
PS150 Total Knee Arthroplasty Outcomes Registry
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 4 sites in 2 countries.
Trial summary
This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years. Data collection will include Radiographic Analysis, Knee Society Evaluation and Adverse Events. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- P.F.C. Sigma PS150 RP Total Knee System
- Type of treatment
- Medical device
- How many people
- 175 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Feb 2015to 3 Nov 2021
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients may be considered for inclusion in the registry if they meet the inclusion criteria below.
Who may be able to join
- Primary total knee replacement for any indication in accordance with the Instructions For Use accompanying the SIGMA PS150 implant.
- Signed Informed Patient Consent
Who cannot join
- There are no exclusion criteria for this registry.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia2 sites
Greenslopes Private Hospital
Greenslopes
Northern Orthopaedics
Sydney
South Korea2 sites
Gachon University Gil Medical Center
Incheon, 405-760
Jeju National University Hospital
Jeju City, 690-767
About this study
Official title: Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System
This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years. Data collection will include Radiographic Analysis, Knee Society Evaluation and Adverse Events.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Being tested
- P.F.C. Sigma PS150 RP Total Knee System
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P.F.C. Sigma PS150 RP Total Knee SystemDevice
Total Knee Arthroplasty - surgical procedure to replace knee with metal implant
| Study group | Role | What they receive |
|---|---|---|
| Participants | P.F.C. Sigma PS150 RP Total Knee System Receives: Device: P.F.C. Sigma PS150 RP Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
Lack of revision with revision meaning no removal or replacement of any TKA component.
Measured: 5 years
Secondary outcomes (7)
Knee Society Score - Knee Score
Descriptive statistics, including change from baseline (post-op minus pre-op)
Measured: 1, 3 & 5 years
Knee Society Score - Function
Descriptive statistics, including change from baseline (post-op minus pre-op)
Measured: 1, 3 & 5 years
Pain sub-question of the Knee Society Score
Descriptive statistics, including change from baseline (post-op minus pre-op)
Measured: 1, 3 & 5 years
Flexion
Descriptive statistics, including change from baseline (post-op minus pre-op)
Measured: 1, 3 & 5 years
Extension
Descriptive statistics, including change from baseline (post-op minus pre-op)
Measured: 1, 3 & 5 years
Radiographic Analysis
Descriptive statistics
Measured: 1, 3 & 5 years
Adverse Events
Type and frequency of adverse events
Measured: 1, 3 & 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study start1 Feb 2015
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 175 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Dekkers, MBBS, Principal investigator, Greenslopes Private Hospital, Brisbane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319291
- Sponsor's protocol ID
- 13004
- Status last verified
- Feb 2023
- First submitted
- 15 Dec 2014
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System
- ClinicalTrials.gov ID
- NCT02319291
- Acronym / sponsor ID
- 13004
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 18 Dec 2014 (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.
This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years. Data collection will include Radiographic Analysis, Knee Society Evaluation and Adverse Events.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: P.F.C. Sigma PS150 RP Total Knee SystemP.F.C. Sigma PS150 RP Total Knee System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients may be considered for inclusion in the registry if they meet the inclusion criteria below.
Key inclusion criteria (2 listed)
- Primary total knee replacement for any indication in accordance with the Instructions For Use accompanying the SIGMA PS150 implant.
- Signed Informed Patient Consent
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this registry.
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 |
|---|---|---|
| P.F.C. Sigma PS150 RP Total Knee SystemTotal Knee Arthroplasty - surgical procedure to replace knee with metal implant | Device | Participants |
Primary outcome
Implant Survivorship
Time frame: 5 years
Lack of revision with revision meaning no removal or replacement of any TKA component.
7 secondary outcomes
Knee Society Score - Knee Score
Time frame: 1, 3 & 5 years
Knee Society Score - Function
Time frame: 1, 3 & 5 years
Pain sub-question of the Knee Society Score
Time frame: 1, 3 & 5 years
Flexion
Time frame: 1, 3 & 5 years
Extension
Time frame: 1, 3 & 5 years
Radiographic Analysis
Time frame: 1, 3 & 5 years
Adverse Events
Time frame: 1, 3 & 5 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 22 Feb 2023.
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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.
Mark Dekkers, MBBS principal investigator
Greenslopes Private Hospital, Brisbane
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 4 sites in 2 countries.
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 1 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 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, 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.
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?
Implant Survivorship (time frame: 5 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 22 Feb 2023.