OsteoarthritisPhase 4NCT00761410
A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
A Phase 4 study testing P.F.C. Sigma RP-F Total Knee Replacement in people with Osteoarthritis, run by DePuy International at 8 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- P.F.C. Sigma RP-F Total Knee Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Oct 2004to May 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged between 45 and 75 years inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who are able to achieve a pre-operative passive range of motion of equal to or greater than 110º.
- 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 who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the P.F.C.® Sigma RPF knee, according to the indications specified in the package insert leaflet.
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.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
- Subjects who are currently involved in any personal injury litigation claims.
- Subjects with a known history of poor compliance to medical treatment.
- Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis.
- Subjects who have morbid obesity i.e. BMI ≥40.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
United Kingdom2 sites
Nottingham City Hospital, Hucknell Road
Nottingham, NG5 1PB
Clifton Park NHS Treatment Centre, Blue Beck Drive, Shipton Road
York
Japan1 site
Kobe University Graduate School Of Medicine, 7-5-1 Kusundki- cho
Chūōku, Kobe
New Zealand1 site
Wellington School Of Medicine Surgical Research Trust, Main Street
Newtown, Wellington Region
South Korea1 site
Kyunghee University Hospital, 1 HoegiDong
Dongdaemun Gu, Seoul
About this study
Official title: A Prospective, Non-Comparative Multi Centre Study to Evaluate the Clinical Performance of the DePuy Press Fit Condylar (P.F.C.) Sigma Rotating Platform High Flexion Knee.
The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.
Read the detailed description
Primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater.
The secondary endpoint is to investigate the survivorship of the P.F.C. Sigma RP-F knee at 1, 2, 3, 5, 10, 15 and 20 years
- Conditions
- Osteoarthritis
- Being tested
- P.F.C. Sigma RP-F Total Knee Replacement
- Keywords
- Arthroplasty, Knee, Replacement, High Flexion, PFC Sigma RP-F
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P.F.C. Sigma RP-F Total Knee ReplacementDevice
An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design
| Study group | Role | What they receive |
|---|---|---|
| P.F.C. Sigma RP-F Total Knee Replacement | Other | An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design Receives: Device: P.F.C. Sigma RP-F Total Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater.
Proportion of cases that have a functionally stable knee (Q10 of Oxford Knee Score is 'rarely/never' or 'sometimes, or just at first'), AND can achieve 1-year post-op passive range of motion of 125 degrees or greater.
Measured: 1 year
Secondary outcomes (6)
Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years.
Measured: 1, 2, 3 and 5 years
American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years
Measured: 1, 2, 3 and 5 years
Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years
Measured: 1, 2, 3 and 5 years
Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years
Measured: 1, 2, 3 and 5 years
Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years
Measured: 1, 2, 3 and 5 years
SF-12 1, 2, 3, 5, 10, 15 and 20 years
Measured: 1, 2, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startOct 2004
- Primary completionFeb 2010
- Study completionMay 2015
Why it stopped: Study was terminated early due to prolonged recruitment period.
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
- 170 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
- NCT00761410
- Sponsor's protocol ID
- CT0153
- Status last verified
- Jun 2016
- First submitted
- 26 Sep 2008
- 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
- A Prospective, Non-Comparative Multi Centre Study to Evaluate the Clinical Performance of the DePuy Press Fit Condylar (P.F.C.) Sigma Rotating Platform High Flexion Knee.
- ClinicalTrials.gov ID
- NCT00761410
- Acronym / sponsor ID
- CT0153
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, Knee, Replacement, High Flexion, PFC Sigma RP-F
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early due to prolonged recruitment period.
- Enrolment
- 170 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Sep 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 if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.
Detailed description
Primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater.
The secondary endpoint is to investigate the survivorship of the P.F.C. Sigma RP-F knee at 1, 2, 3, 5, 10, 15 and 20 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P.F.C. Sigma RP-F Total Knee Replacement | Other | Device: P.F.C. Sigma RP-F Total Knee ReplacementAn orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects, aged between 45 and 75 years inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who are able to achieve a pre-operative passive range of motion of equal to or greater than 110º.
- 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 who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
Key exclusion criteria (8 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
- Subjects who are currently involved in any personal 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 |
|---|---|---|
| P.F.C. Sigma RP-F Total Knee ReplacementAn orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design | Device | P.F.C. Sigma RP-F Total Knee Replacement |
Primary outcome
Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater.
Time frame: 1 year
Proportion of cases that have a functionally stable knee (Q10 of Oxford Knee Score is 'rarely/never' or 'sometimes, or just at first'), AND can achieve 1-year post-op passive range of motion of 125 degrees or greater.
6 secondary outcomes
Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years.
Time frame: 1, 2, 3 and 5 years
American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years
Time frame: 1, 2, 3 and 5 years
Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years
Time frame: 1, 2, 3 and 5 years
Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years
Time frame: 1, 2, 3 and 5 years
Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years
Time frame: 1, 2, 3 and 5 years
SF-12 1, 2, 3, 5, 10, 15 and 20 years
Time frame: 1, 2, 3 and 5 years
Results and safety
The study was stopped early (reason given: Study was terminated early due to prolonged recruitment period.). 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.
8 sites in 7 countries: 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 RP-F Total Knee Replacement in people with Osteoarthritis, run by DePuy International at 8 sites in 7 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 6 inclusion and 8 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 8 sites in United Kingdom, India, Japan, New Zealand, Singapore and 2 more countries. 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: Study was terminated early due to prolonged recruitment period.). 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?
Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater. (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.