OsteoarthritisNCT00289094
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
A study testing Total Knee Replacement in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
- What is being tested?
- Total Knee Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2001to 26 Dec 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 of bone
Who cannot join
- Prior ipsilateral TKA
- Metabolic disorders
- Joint replacement due to autoimmune disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Billings, Montana, 59101
Study site
Vancouver, Washington, 98664
About this study
Official title: Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
Read the detailed description
This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis of Bone
- Being tested
- Total Knee Replacement
- 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 ReplacementDevice
Also called P.F.C.® Sigma™ RP Cruciate Retaining Knee System
Rotating Platform (RP) Cruciate Retaining Knee System
Total knee replacementDevice
Also called P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
Fixed Cruciate Retaining Knee System
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System Receives: Device: Total Knee Replacement |
| 2 | Active comparator | P.F.C.® Sigma™ Fixed Cruciate Retaining 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 Scores
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 (3)
Complications/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 Mar 2001
- Primary completion26 Dec 2007
- Study completion26 Dec 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
- 99 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, CCRC, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289094
- Sponsor's protocol ID
- SRP-2
- Status last verified
- Jul 2022
- First submitted
- 7 Feb 2006
- Last updated
- 13 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
- ClinicalTrials.gov ID
- NCT00289094
- Acronym / sponsor ID
- SRP-2
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis of Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2001 (actual)
- Primary completion
- 26 Dec 2007 (actual)
- Study completion
- 26 Dec 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 purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
Detailed description
This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining 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 ReplacementP.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System |
| 2 | Active comparator | Device: Total knee replacementP.F.C.® Sigma™ Fixed Cruciate Retaining Knee System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Osteoarthritis
- Rheumatoid Arthritis
- Other inflammatory arthritis
- Avascular necrosis of bone
Key exclusion criteria (3 listed)
- Prior ipsilateral TKA
- Metabolic disorders
- Joint replacement due to autoimmune disorders
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 ReplacementAlso: P.F.C.® Sigma™ RP Cruciate Retaining Knee SystemRotating Platform (RP) Cruciate Retaining Knee System | Device | 1 |
| Total knee replacementAlso: P.F.C.® Sigma™ Fixed Cruciate Retaining Knee SystemFixed Cruciate Retaining Knee System | Device | 2 |
Primary outcome
Knee Society Scores
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.
3 secondary outcomes
Complications/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 13 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
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
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, CCRC study director
DePuy Orthopaedics
2 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 Replacement in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 2 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 4 inclusion and 3 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 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Scores (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 13 Sep 2022.