OsteoarthritisPhase 4TC3NCT00733681
The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty
A Phase 4 study testing PFC Sigma RP TC3 Revision knee system in people with Osteoarthritis, run by DePuy International at 9 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- PFC Sigma RP TC3 Revision knee system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Mar 2004to Mar 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects over the age of 21 years (and skeletally mature).
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects whose primary diagnosis includes non-inflammatory or inflammatory degenerative joint disease.
- Subjects who require revision of any previous knee arthroplasty.
- Subjects who, in the opinion of the Clinical Investigator, are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
- Subjects who require revision of the femoral and/or tibial components. (Both components must be replaced as part of the study.)
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study (including malignancy, severe osteoporosis or disabling musculoskeletal problems).
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 60 days (excluding any primary knee replacement study).
- Subjects who are currently involved in any injury litigation claims.
- Subjects with global instability, deficient extensor mechanism or severe bone loss (eg. due to fracture or tumour resection).
- Subjects who have had their contralateral knee replaced within the previous 6-month period.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United Kingdom5 sites
Western Infirmary
Glasgow, G11 6NT
Princess Alexandra Hospital NHS Site
Harlow, Essex, CM20 1QX
Leicester General Infirmary
Leicester, LE3 9QP
City Hospital
Nottingham, Nottinghamshire, NG5 1PB
Robert Jones & Agnes Hunt Orthopaedic Hospital
Oswestry, WY10 7AG
Germany2 sites
Orthopaedische Universitaetsklinik
Heidelberg, D-69118
Asklepios Klinik
Lindenlohe
About this study
Official title: A Prospective, Non-comparative Study to Evaluate the Performance of the DePuy P.F.C. Sigma Rotating Platform TC3 Knee Prosthesis in Revision Knee Arthroplasty.
The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement.
Read the detailed description
Primary outcome: Implant survival at 5 years Secondary Outcomes:Evidence of clinical and functional outcome determined by the Knee Society Score, anterior knee pain (Patellar Score). Evidence of health related quality of life determined by WOMAC OA index. Patient satisfaction at 1 and 5 years. Radiographic analysis according to Knee society guidelines. Implant survival annually to 15 years.
- Conditions
- Osteoarthritis
- Being tested
- PFC Sigma RP TC3 Revision knee system
- Keywords
- Arthroplasty, Replacement, Knee, Prosthesis Failure, Revision surgery
- Medical subject headings
- Osteoarthritis, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFC Sigma RP TC3 Revision knee systemDevice
Also called Sigma RP TC3
Orthopaedic implant system for revision total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| PFC Sigma RP TC3 Revision Knee System | Experimental | Revision knee surgery with the PFC Sigma RP TC3 Revision Knee System (mobile bearing). Receives: Device: PFC Sigma RP TC3 Revision knee system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
Measured: 5 years
Secondary outcomes (1)
Clinical/functional outcome (Knee Society & Patellar Scores). Health-related QoL (WOMAC OA Index). Patient Satisfaction at 1 & 5 years (2 patient questions). Radiographic analysis (Knee Society guidelines). Annual implant survival to 15 years.
Measured: 6 months, 1, 2, 3, 5, 10 and 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startMar 2004
- Primary completionFeb 2014
- Study completionMar 2014
Why it stopped: Subjects were no longer able to remain compliant with follow-up intervals
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J James, FRCS, Principal investigator, City Hospital, Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733681
- Sponsor's protocol ID
- CT 02/14
- Acronym
- TC3
- Status last verified
- Jan 2015
- First submitted
- 11 Aug 2008
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-comparative Study to Evaluate the Performance of the DePuy P.F.C. Sigma Rotating Platform TC3 Knee Prosthesis in Revision Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT00733681
- Acronym / sponsor ID
- TC3 / CT 02/14
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, Replacement, Knee, Prosthesis Failure, Revision surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subjects were no longer able to remain compliant with follow-up intervals
- Enrolment
- 181 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Aug 2008 (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 evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement.
Detailed description
Primary outcome: Implant survival at 5 years Secondary Outcomes:Evidence of clinical and functional outcome determined by the Knee Society Score, anterior knee pain (Patellar Score). Evidence of health related quality of life determined by WOMAC OA index. Patient satisfaction at 1 and 5 years. Radiographic analysis according to Knee society guidelines. Implant survival annually to 15 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PFC Sigma RP TC3 Revision Knee System | Experimental | Device: PFC Sigma RP TC3 Revision knee systemRevision knee surgery with the PFC Sigma RP TC3 Revision Knee System (mobile bearing). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects over the age of 21 years (and skeletally mature).
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects whose primary diagnosis includes non-inflammatory or inflammatory degenerative joint disease.
- Subjects who require revision of any previous knee arthroplasty.
Key exclusion criteria (7 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study (including malignancy, severe osteoporosis or disabling musculoskeletal problems).
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 60 days (excluding any primary knee replacement study).
- Subjects who are currently involved in any injury litigation claims.
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 |
|---|---|---|
| PFC Sigma RP TC3 Revision knee systemAlso: Sigma RP TC3Orthopaedic implant system for revision total knee replacement | Device | PFC Sigma RP TC3 Revision Knee System |
Primary outcome
Implant survival
Time frame: 5 years
1 secondary outcome
Clinical/functional outcome (Knee Society & Patellar Scores). Health-related QoL (WOMAC OA Index). Patient Satisfaction at 1 & 5 years (2 patient questions). Radiographic analysis (Knee Society guidelines). Annual implant survival to 15 years.
Time frame: 6 months, 1, 2, 3, 5, 10 and 15 years
Results and safety
The study was stopped early (reason given: Subjects were no longer able to remain compliant with follow-up intervals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
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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.
Peter J James, FRCS principal investigator
City Hospital, Nottingham
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PFC Sigma RP TC3 Revision knee system in people with Osteoarthritis, run by DePuy International at 9 sites in 4 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Germany, France, Switzerland. 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 was stopped early (reason given: Subjects were no longer able to remain compliant with follow-up intervals). 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?
Implant survival (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 Jan 2015.