Knee OsteoarthritisPhase 4NCT00733928
The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly
A Phase 4 study testing PFC Sigma knee with all-poly tibial component and PFC Sigma knee with metal backed tibia in people with Knee Osteoarthritis, run by DePuy International at 1 site in United Kingdom.
Trial summary
The primary objective of this investigation was to evaluate \& compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PFC Sigma knee with all-poly tibial component and PFC Sigma knee with metal backed tibia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 1999to 1 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects requiring a primary knee replacement.
- Subjects aged 65 years or more.
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subjects with a primary diagnosis of osteoarthritis or rheumatoid arthritis.
Who cannot join
- Subjects who have had a previous surgery of the operative knee except menisectomy and arthroscopy.
- Subjects who have had a renal transplant.
- Subjects with a metabolic bone disorder.
- Subjects who, in the opinion of the Clinical Investigator, have an existing condition, e.g. Paget's disease etc. that would compromise their participation and follow-up in this clinical investigation.
- Subjects whose contralateral knee is already included in this study.
- Subjects who have a history of active joint sepsis.
Show all 9Show fewer
- Subjects who have a recent history of high dose systemic corticosteroids.
- Subjects with psycho-social disorders or physical disabilities that would limit rehabilitation.
- Subjects requiring a bone graft.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Orthopaedics, Freeman Hospital
Newcastle upon Tyne, NE7 7DN
About this study
Official title: Randomised Prospective Comparison of P.F.C All-polyethylene Versus Metal-backed Tibial Component. A Clinical, Radiological and Roentgen Stereophotogrammetric Analysis (RSA) Study.
The primary objective of this investigation was to evaluate \& compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA.
The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components.
Read the detailed description
Using RSA, is it possible to evaluate the performance of both the all polyethylene and metal backed tibia components to determine whether there are differences in migration, if present, across the tibial components.
The original protocol intended to perform clinical assessment using the Nottingham Knee Score and the Knee Society Clinical rating system pre-and post-operatively, at six months, 1 year, and annually thereafter. Per Protocol Amendment 01 (effective June 18, 1999) clinical data would also be collected via the SF-12 questionnaire. Radiological evaluation would also use the Knee Society scoring system at the same time points. However, data collected included only the SF-12 and Oxford Knee Scores, comparing change from baseline at 6, 12, and 24 months after surgery.
- Conditions
- Knee Osteoarthritis
- Being tested
- PFC Sigma knee with all-poly tibial component, PFC Sigma knee with metal backed tibia
- Keywords
- Arthroplasty,, Replacement,, Knee,, P.F.C., Sigma, all-polyethylene
- 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 knee with all-poly tibial componentDevice
Orthopaedic implant for total knee replacement with an all-polyethylene tibial component
PFC Sigma knee with metal backed tibiaDevice
Orthopaedic implant for total knee replacement with a metal-backed tibial component
| Study group | Role | What they receive |
|---|---|---|
| 1 - All Polyethylene Tibia | Other | Total knee replacement with an all polyethylene tibial tray Receives: Device: PFC Sigma knee with all-poly tibial component |
| 2 - Poly & Metal Tibia | Active comparator | Total knee replacement with a metal-backed tibial component Receives: Device: PFC Sigma knee with metal backed tibia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using RSA it is possible to evaluate the performance of both the all-polyethylene and metal-backed tibia components to determine whether there are differences in migration between the two components
Measured: 2 years
Secondary outcomes (1)
Comparative evaluation of any post-operative variation between subjects receiving all-polyethylene and metal-backed tibia components in change from baseline at each post operative time points in terms of SF 12 and OKS
Measured: 6 months, 1 year and 2 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 Oct 1999
- Primary completion1 May 2005
- Study completion1 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 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
- NCT00733928
- Sponsor's protocol ID
- CT 99/26
- Status last verified
- Mar 2025
- First submitted
- 11 Aug 2008
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller SD, Deehan DJ, Holland JP, Outterside SE, Kirk LM, Gregg PJ, McCaskie AW. Should we reconsider all-polyethylene tibial implants in total knee replacement? J Bone Joint Surg Br. 2006 Dec;88(12):1596-602. doi: 10.1302/0301-620X.88B12.17695.
PubMed 17159170
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Prospective Comparison of P.F.C All-polyethylene Versus Metal-backed Tibial Component. A Clinical, Radiological and Roentgen Stereophotogrammetric Analysis (RSA) Study.
- ClinicalTrials.gov ID
- NCT00733928
- Acronym / sponsor ID
- CT 99/26
- Conditions
- Knee Osteoarthritis
- Keywords
- Arthroplasty,, Replacement,, Knee,, P.F.C., Sigma, all-polyethylene
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 1999 (actual)
- Primary completion
- 1 May 2005 (actual)
- Study completion
- 1 Mar 2015 (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 primary objective of this investigation was to evaluate \& compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA.
The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components.
Detailed description
Using RSA, is it possible to evaluate the performance of both the all polyethylene and metal backed tibia components to determine whether there are differences in migration, if present, across the tibial components.
The original protocol intended to perform clinical assessment using the Nottingham Knee Score and the Knee Society Clinical rating system pre-and post-operatively, at six months, 1 year, and annually thereafter. Per Protocol Amendment 01 (effective June 18, 1999) clinical data would also be collected via the SF-12 questionnaire. Radiological evaluation would also use the Knee Society scoring system at the same time points. However, data collected included only the SF-12 and Oxford Knee Scores, comparing change from baseline at 6, 12, and 24 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - All Polyethylene Tibia | Other | Device: PFC Sigma knee with all-poly tibial componentTotal knee replacement with an all polyethylene tibial tray |
| 2 - Poly & Metal Tibia | Active comparator | Device: PFC Sigma knee with metal backed tibiaTotal knee replacement with a metal-backed tibial component |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subjects requiring a primary knee replacement.
- Subjects aged 65 years or more.
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subjects with a primary diagnosis of osteoarthritis or rheumatoid arthritis.
Key exclusion criteria (9 listed)
- Subjects who have had a previous surgery of the operative knee except menisectomy and arthroscopy.
- Subjects who have had a renal transplant.
- Subjects with a metabolic bone disorder.
- Subjects who, in the opinion of the Clinical Investigator, have an existing condition, e.g. Paget's disease etc. that would compromise their participation and follow-up in this clinical investigation.
- Subjects whose contralateral knee is already included in this study.
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 knee with all-poly tibial componentOrthopaedic implant for total knee replacement with an all-polyethylene tibial component | Device | 1 - All Polyethylene Tibia |
| PFC Sigma knee with metal backed tibiaOrthopaedic implant for total knee replacement with a metal-backed tibial component | Device | 2 - Poly & Metal Tibia |
Primary outcome
Using RSA it is possible to evaluate the performance of both the all-polyethylene and metal-backed tibia components to determine whether there are differences in migration between the two components
Time frame: 2 years
1 secondary outcome
Comparative evaluation of any post-operative variation between subjects receiving all-polyethylene and metal-backed tibia components in change from baseline at each post operative time points in terms of SF 12 and OKS
Time frame: 6 months, 1 year and 2 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 30 Mar 2025.
- Results publication: PubMed 17159170Muller SD, Deehan DJ, Holland JP, Outterside SE, Kirk LM, Gregg PJ, McCaskie AW. Should we reconsider all-polyethylene tibial implants in total knee replacement? J Bone Joint Surg Br. 2006 Dec;88(12):1596-602. doi: 10.1302/0301-620X.88B12.17695.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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 knee with all-poly tibial component and PFC Sigma knee with metal backed tibia 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: finished, as of the sponsor's last update on 30 Mar 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 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?
Using RSA it is possible to evaluate the performance of both the all-polyethylene and metal-backed tibia components to determine whether there are differences in migration between the two components (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00733928, which also lists 1 linked publication.
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 30 Mar 2025.