OsteoarthritisNCT00289107
Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA
A study testing Total Knee Arthroplasty and Total knee replacement in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 3 sites in United States.
Trial summary
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Other Inflammatory Arthritis
- What is being tested?
- Total Knee Arthroplasty and Total knee replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2001to 1 Nov 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis
- Rheumatoid arthritis
- Other inflammatory arthritis
- Avascular necrosis (AVN) of bone
- Post-Traumatic Arthritis
- Juvenile Rheumatoid Arthritis
Who cannot join
- History of recent/active joint sepsis.
- Charcot neuropathy.
- Psycho-social disorders that would limit rehabilitation.
- Greater than 75 years of age at the time of surgery.
- Prior ipsilateral knee arthroplasty.
- Metabolic disorders of calcified tissues, such as Paget's disease.
Show all 9Show fewer
- Severe diabetes mellitus.
- Joint replacement due to autoimmune disorders.
- Skeletal immaturity
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Austin, Texas, 78746
Study site
Greensboro, North Carolina, 27408
Study site
Lakewood, Washington, 98499
About this study
Official title: Multi-center, Prospective, Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
Read the detailed description
The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Other Inflammatory Arthritis, Post-Traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis
- Being tested
- Total Knee Arthroplasty, Total knee replacement
- Keywords
- Total Knee Replacement, Knee Prosthesis
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Juvenile, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyDevice
Also called P.F.C.® Sigma™ RP Cruciate Substituting Knee System
Rotating Platform (RP) Cruciate Substituting Knee System
Total knee replacementDevice
Also called P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System
Fixed Cruciate Substituting Knee System
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System Receives: Device: Total Knee Arthroplasty |
| 2 | Active comparator | P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System Receives: Device: Total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.
Measured: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary outcomes (4)
Complications
Measured: On-going to end of study
Revisions
Measured: On-going to end of study
Medical Imaging
Measured: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
SF-12 Patient Outcomes
Measured: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study start1 Apr 2001
- Primary completion1 Nov 2007
- Study completion1 Nov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tammy L O'Dell, EMT, CCRA, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289107
- Sponsor's protocol ID
- SRP-3
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2006
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases
- ClinicalTrials.gov ID
- NCT00289107
- Acronym / sponsor ID
- SRP-3
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Other Inflammatory Arthritis, Post-Traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis
- Keywords
- Total Knee Replacement, Knee Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2001 (actual)
- Primary completion
- 1 Nov 2007 (actual)
- Study completion
- 1 Nov 2007 (actual)
- First posted
- 9 Feb 2006 (estimated)
- Results
- Posted 10 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
Detailed description
The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Total Knee ArthroplastyP.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System |
| 2 | Active comparator | Device: Total knee replacementP.F.C.® Sigma™ Fixed Cruciate Substituting Knee System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Osteoarthritis
- Rheumatoid arthritis
- Other inflammatory arthritis
- Avascular necrosis (AVN) of bone
- Post-Traumatic Arthritis
Key exclusion criteria (9 listed)
- History of recent/active joint sepsis.
- Charcot neuropathy.
- Psycho-social disorders that would limit rehabilitation.
- Greater than 75 years of age at the time of surgery.
- Prior ipsilateral knee arthroplasty.
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 |
|---|---|---|
| Total Knee ArthroplastyAlso: P.F.C.® Sigma™ RP Cruciate Substituting Knee SystemRotating Platform (RP) Cruciate Substituting Knee System | Device | 1 |
| Total knee replacementAlso: P.F.C.® Sigma™ Fixed Cruciate Substituting Knee SystemFixed Cruciate Substituting Knee System | Device | 2 |
Primary outcome
Knee Society Score
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.
4 secondary outcomes
Complications
Time frame: On-going to end of study
Revisions
Time frame: On-going to end of study
Medical Imaging
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
SF-12 Patient Outcomes
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tammy L O'Dell, EMT, CCRA study director
DePuy Orthopaedics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty and Total knee replacement in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 3 sites in United States.
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 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Knee Society Score (time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 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 3 May 2023.