Osteoarthritis, KneePhase 4NCT00208286
P.F.C. Sigma Fixed Versus P.F.C. RP Mobile Bearing Total Knee Systems
A Phase 4 study testing PFC Sigma Fixed Bearing and PFC Sigma Mobile Bearing in people with Osteoarthritis, Knee, run by DePuy International at 1 site in United Kingdom.
Trial summary
This post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The first patient had surgery on November 8, 2001 and the final patient had surgery on July 29, 2005. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PFC Sigma Fixed Bearing and PFC Sigma Mobile Bearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2001to Mar 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Administrative - The patient or their authorised representative is able to understand the evaluation, is able to give voluntary written informed consent and will comply with the post operative follow up regime.
- Age - There are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation.
- Sex - Male or female (providing that they are not pregnant) may be recruited to the evaluation.
- Diagnosis - patients that require a tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
- Suitability - Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing tibial knee system and are suitable for patella resurfacing.
Who cannot join
- Patients with rheumatoid arthritis.
- Patients requiring revision total knee arthroplasty surgery.
- Patients with any tibial deformity requiring tibial component augmentation.
- Patients that in the opinion of the clinical investigators require a constrained prosthesis.
- Patients with a known history of poor compliance to medical treatment.
- Patients who are known drug or alcohol abusers.
Show all 10Show fewer
- Patients with a pathology which in the opinion of the clinical investigator will adversely affect healing.
- Patients who are currently participating in another clinical evaluation.
- Patients with other disorders which in the opinion of the Clinical Investigator will / could impair rehabilitation.
- Contra-indications for use of the device, as detailed in the package insert.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma Rotating Platform (Mobile Bearing) Total Knee Systems.
This post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The first patient had surgery on November 8, 2001 and the final patient had surgery on July 29, 2005. There were 120 knees consented by a single site, which was the planned sample size in the study protocol, with 117 receiving one of the study devices. The study was terminated as the primary outcome was met and the investigator decided to conduct the study without sponsor support after 2009.
Read the detailed description
Performance and safety will be assessed using the following surgeon and patient based outcome tools:
- American Knee Society Knee and Function Scores
- Knee Society Radiological Analysis
- Oxford Knee Score
- SF 12 Score
- Anterior Knee Pain Score
Specific objectives of the evaluation being to assess the following:
- Improvement in functional recovery
- Incidence of anterior knee pain
- Improvement in Quality of life
- Incidence of tibial loosening
- Incidence of excessive polyethylene wear
- Conditions
- Osteoarthritis, Knee
- Being tested
- PFC Sigma Fixed Bearing, PFC Sigma Mobile Bearing
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFC Sigma Fixed BearingDevice
PFC Sigma Fixed Bearing system for use in total knee arthroplasty
PFC Sigma Mobile BearingDevice
PFC Sigma Mobile Bearing system for use in total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| PFC Sigma Fixed Bearing | Other | PFC Sigma Fixed Bearing system for use in total knee arthroplasty Receives: Device: PFC Sigma Fixed Bearing |
| PFC Sigma Mobile Bearing | Active comparator | PFC Sigma Mobile Bearing system for use in total knee arthroplasty Receives: Device: PFC Sigma Mobile Bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare Range of Motion (ROM) between subjects receiving Sigma Rotating Platform mobile bearing and Sigma fixed bearing components
Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.
Measured: 1 year
Secondary outcomes (7)
Change in SF-12 Physical and Mental Component Scores from Baseline to 1 and 2 years
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality. The response metric is the change score, or delta, from pre-operative assessment to post-operative assessment.
Measured: 1 and 2 years
Change in American Knee Society Knee and Function Scores from Baseline to 1 and 2 years
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of Walking and Stair Climbing ability.
Measured: 1 and 2 years
Change in Oxford Knee Score from Baseline to 1 and 2 years
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Measured: 1 and 2 years
Change in Anterior Knee Pain from Baseline to 1 and 2 years
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe.
Measured: 1 and 2 years
Incidence of Femoral Radiolucencies at one year
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and > 2mm, the number of knees is displayed.
Measured: 6 weeks to 3 Months through 1 year
Incidence of Tibial Radiolucencies at one year
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and > 2mm, the number of knees is displayed.
Measured: 6 weeks to 3 Months through 1 year
Incidence of Patellar Radiolucencies at one year
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and > 2mm, the number of knees is displayed.
Measured: 6 weeks to 3 Months through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2001
- Primary completionOct 2006
- Study completionMar 2015
Why it stopped: Primary study outcome achieved; investigator decided to conduct the study without sponsor support after 2009.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 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
- NCT00208286
- Sponsor's protocol ID
- CT0101
- Status last verified
- Jun 2016
- First submitted
- 13 Sep 2005
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma Rotating Platform (Mobile Bearing) Total Knee Systems.
- ClinicalTrials.gov ID
- NCT00208286
- Acronym / sponsor ID
- CT0101
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary study outcome achieved; investigator decided to conduct the study without sponsor support after 2009.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Oct 2006 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Sep 2005 (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 post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The first patient had surgery on November 8, 2001 and the final patient had surgery on July 29, 2005. There were 120 knees consented by a single site, which was the planned sample size in the study protocol, with 117 receiving one of the study devices. The study was terminated as the primary outcome was met and the investigator decided to conduct the study without sponsor support after 2009.
Detailed description
Performance and safety will be assessed using the following surgeon and patient based outcome tools:
- American Knee Society Knee and Function Scores
- Knee Society Radiological Analysis
- Oxford Knee Score
- SF 12 Score
- Anterior Knee Pain Score
Specific objectives of the evaluation being to assess the following:
- Improvement in functional recovery
- Incidence of anterior knee pain
- Improvement in Quality of life
- Incidence of tibial loosening
- Incidence of excessive polyethylene wear
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFC Sigma Fixed Bearing | Other | Device: PFC Sigma Fixed BearingPFC Sigma Fixed Bearing system for use in total knee arthroplasty |
| PFC Sigma Mobile Bearing | Active comparator | Device: PFC Sigma Mobile BearingPFC Sigma Mobile Bearing system for use in total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Administrative - The patient or their authorised representative is able to understand the evaluation, is able to give voluntary written informed consent and will comply with the post operative follow up regime.
- Age - There are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation.
- Sex - Male or female (providing that they are not pregnant) may be recruited to the evaluation.
- Diagnosis - patients that require a tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
- Suitability - Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing tibial knee system and are suitable for patella resurfacing.
Key exclusion criteria (10 listed)
- Patients with rheumatoid arthritis.
- Patients requiring revision total knee arthroplasty surgery.
- Patients with any tibial deformity requiring tibial component augmentation.
- Patients that in the opinion of the clinical investigators require a constrained prosthesis.
- Patients with a known history of poor compliance to medical treatment.
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 Fixed BearingPFC Sigma Fixed Bearing system for use in total knee arthroplasty | Device | PFC Sigma Fixed Bearing |
| PFC Sigma Mobile BearingPFC Sigma Mobile Bearing system for use in total knee arthroplasty | Device | PFC Sigma Mobile Bearing |
Primary outcome
To Compare Range of Motion (ROM) between subjects receiving Sigma Rotating Platform mobile bearing and Sigma fixed bearing components
Time frame: 1 year
Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.
7 secondary outcomes
Change in SF-12 Physical and Mental Component Scores from Baseline to 1 and 2 years
Time frame: 1 and 2 years
Change in American Knee Society Knee and Function Scores from Baseline to 1 and 2 years
Time frame: 1 and 2 years
Change in Oxford Knee Score from Baseline to 1 and 2 years
Time frame: 1 and 2 years
Change in Anterior Knee Pain from Baseline to 1 and 2 years
Time frame: 1 and 2 years
Incidence of Femoral Radiolucencies at one year
Time frame: 6 weeks to 3 Months through 1 year
Incidence of Tibial Radiolucencies at one year
Time frame: 6 weeks to 3 Months through 1 year
Incidence of Patellar Radiolucencies at one year
Time frame: 6 weeks to 3 Months through 1 year
Results and safety
The study was stopped early (reason given: Primary study outcome achieved; investigator decided to conduct the study without sponsor support after 2009.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 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.
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 PFC Sigma Fixed Bearing and PFC Sigma Mobile Bearing in people with Osteoarthritis, Knee, 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 5 inclusion and 10 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 20 Jun 2016. 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: Primary study outcome achieved; investigator decided to conduct the study without sponsor support after 2009.). 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 Compare Range of Motion (ROM) between subjects receiving Sigma Rotating Platform mobile bearing and Sigma fixed bearing components (time frame: 1 year). 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 20 Jun 2016.