Knee OsteoarthritisPhase 4NCT00734110
Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
A Phase 4 study testing P.F.C. Sigma Total Knee System in people with Knee Osteoarthritis, run by DePuy International at 1 site in United Kingdom.
Trial summary
The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and symptomology of each knee following surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- P.F.C. Sigma Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 723 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2000to 1 Jun 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have given voluntary written informed consent to participate in this study.
- Patients for whom primary Total Knee Replacement is indicated due to degenerative joint disease, including rheumatoid arthritis, osteoarthritis, avascular necrosis, and post-traumatic arthritis, which is causing pain, deformity, or limitation of function uncontrolled by medical treatment.
- Patients who, in the opinion of the Investigator, are able to understand this study, co-operate with the investigational procedures and are willing to return to the hospital for all the scheduled post-operative follow-ups.
- Male or female patients who are skeletally mature and for whom an appropriate size of device is available.
Who cannot join
- Patients scheduled for Revision Total Knee Arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
- Patients experiencing any condition that may, in the opinion of the Investigator, interfere with the Total Knee Replacement's survival or outcome (e.g. Paget's disease, Charcot's disease, severe osteoporosis, etc.)
- Patients who have evidence of active infections which may spread to other areas of the body (e.g. osteomyelitis, pyrogenic infection of the knee joint, overt infection, etc.).
- Patients who are currently participating in any other clinical investigation of a device or pharmaceutical.
- Patients having non-contained defects in the tibia or femur necessitating bone graft.
- Patients with psychosocial disorders that would limit rehabilitation or follow-up.
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- Subjects with a known history of poor compliance to medical treatment.
- Subjects who are known drug or alcohol abusers.
- Other contraindications for the use of the P.F.C. ® S Knee System as listed in the package insert.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Princess Alexandra Hospital NHS Trust
Harlow, Essex, CM20 1QX
About this study
Official title: Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System
The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and symptomology of each knee following surgery.
In addition, any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported directly to the Sponsor. The data are to be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum of 5 years.
Read the detailed description
The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported.
- Conditions
- Knee Osteoarthritis
- Being tested
- P.F.C. Sigma Total Knee System
- Keywords
- Arthroplasty, Replacement, Knee, P.F.C. Sigma RPF, Sigma RP
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P.F.C. Sigma Total Knee SystemDevice
Also called Sigma Fixed Bearing Total Knee System
An orthopaedic implant for total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| P.F.C. Sigma Total Knee Replacement System | Experimental | Primary total knee arthroplasty using the fixed bearing P.F.C. Sigma Total Knee Replacement System. Receives: Device: P.F.C. Sigma Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals
Measured: 5 years
Secondary outcomes (1)
The secondary outcomes are any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported.
Measured: 6 weeks, 1, 2, 5 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 start1 Jul 2000
- Primary completion1 Apr 2009
- Study completion1 Jun 2010
Why it stopped: The study achieved the stated objective to record pre \& post operative outcomes at a minimum 5 years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 723 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734110
- Sponsor's protocol ID
- CT 99/24
- Status last verified
- Oct 2025
- First submitted
- 11 Aug 2008
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System
- ClinicalTrials.gov ID
- NCT00734110
- Acronym / sponsor ID
- CT 99/24
- Conditions
- Knee Osteoarthritis
- Keywords
- Arthroplasty, Replacement, Knee, P.F.C. Sigma RPF, Sigma RP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study achieved the stated objective to record pre \& post operative outcomes at a minimum 5 years.
- Enrolment
- 723 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2000 (actual)
- Primary completion
- 1 Apr 2009 (actual)
- Study completion
- 1 Jun 2010 (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 main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and symptomology of each knee following surgery.
In addition, any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported directly to the Sponsor. The data are to be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum of 5 years.
Detailed description
The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P.F.C. Sigma Total Knee Replacement System | Experimental | Device: P.F.C. Sigma Total Knee SystemPrimary total knee arthroplasty using the fixed bearing P.F.C. Sigma Total Knee Replacement System. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have given voluntary written informed consent to participate in this study.
- Patients for whom primary Total Knee Replacement is indicated due to degenerative joint disease, including rheumatoid arthritis, osteoarthritis, avascular necrosis, and post-traumatic arthritis, which is causing pain, deformity, or limitation of function uncontrolled by medical treatment.
- Patients who, in the opinion of the Investigator, are able to understand this study, co-operate with the investigational procedures and are willing to return to the hospital for all the scheduled post-operative follow-ups.
- Male or female patients who are skeletally mature and for whom an appropriate size of device is available.
Key exclusion criteria (9 listed)
- Patients scheduled for Revision Total Knee Arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
- Patients experiencing any condition that may, in the opinion of the Investigator, interfere with the Total Knee Replacement's survival or outcome (e.g. Paget's disease, Charcot's disease, severe osteoporosis, etc.)
- Patients who have evidence of active infections which may spread to other areas of the body (e.g. osteomyelitis, pyrogenic infection of the knee joint, overt infection, etc.).
- Patients who are currently participating in any other clinical investigation of a device or pharmaceutical.
- Patients having non-contained defects in the tibia or femur necessitating bone graft.
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 Total Knee SystemAlso: Sigma Fixed Bearing Total Knee SystemAn orthopaedic implant for total knee replacement | Device | P.F.C. Sigma Total Knee Replacement System |
Primary outcome
To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals
Time frame: 5 years
1 secondary outcome
The secondary outcomes are any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported.
Time frame: 6 weeks, 1, 2, 5 years
Results and safety
The study was stopped early (reason given: The study achieved the stated objective to record pre \& post operative outcomes at a minimum 5 years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing P.F.C. Sigma Total Knee System in people with Knee Osteoarthritis, run by DePuy International at 1 site in United Kingdom.
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 4 inclusion and 9 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 10 Oct 2025. 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 United Kingdom. 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: The study achieved the stated objective to record pre \& post operative outcomes at a minimum 5 years.). 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?
To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals (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 10 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.