Non-inflammatory ArthritisNCT00380861
Does Implant Design Improve Postoperative Flexion?
A study testing Total knee replacement using the PFC Sigma RPF knee implant. and Total knee replacement using the PFC Sigma RP knee implant in people with Non-inflammatory Arthritis, run by DePuy Orthopaedics at 4 sites in United States.
Trial summary
This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Non-inflammatory Arthritis
- What is being tested?
- Total knee replacement using the PFC Sigma RPF knee implant. and Total knee replacement using the PFC Sigma RP knee implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2006to 1 Dec 2009
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-Inflammatory Arthritis
- Age = 40-70 years
- Male or female
- Suitable for devices in study
- Needing primary simultaneous bilateral knee replacements
- Willing to consent and authorize release of personal health information
- Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,
Who cannot join
- Existing conditions that would compromise participation
- Multiple joint involvement
- Pregnant/lactating women
- Inflammatory arthritis
- Fixed flexion contracture greater than 20 degrees
- Previous knee replacement of any type
Show all 11Show fewer
- Needing device(s) not specified in protocol
- The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up
- Those who have participated in an investigation in the last 3 months
- Those involved in personal injury litigation, medical-legal or workers compensation claims
- Failure to follow surgical technique details specified in the protocol
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Doug Dennis
Denver, Colorado, 80210
University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
Iowa City, Iowa, 01075
Heekin Orthopaedics
Jacksonville, Florida, 32204
Lakewood Orthopaedic Surgeons
Lakewood, Washington, 98499
About this study
Official title: Does Implant Design Improve Postoperative Flexion?A Prospective, Randomized, Comparative, Multi-center Study Comparing PFC® Sigma™ RP Knee Versus PFC® Sigma™ RP-F Implanted in Simultaneous Bilateral Subjects
This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day.
Read the detailed description
The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.
- Conditions
- Non-inflammatory Arthritis
- Being tested
- Total knee replacement using the PFC Sigma RPF knee implant., Total knee replacement using the PFC Sigma RP knee implant
- Keywords
- Total Knee Replacement, Flexion, Range of Motion, Activities of Daily Living, Implant design, Subject Satisfaction, Non-inflammatory arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacement using the PFC Sigma RPF knee implant.Device
Total knee replacement
Total knee replacement using the PFC Sigma RP knee implantDevice
Total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| PFC Sigma RP-F | Active comparator | PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique. Receives: Device: Total knee replacement using the PFC Sigma RPF knee implant. |
| PFC Sigma RP | Active comparator | P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a special insert that helps the knee move more like it did before the knee replacement. Receives: Device: Total knee replacement using the PFC Sigma RP knee implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Passive Flexion at 6 Months
The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.
Measured: 6 months
Secondary outcomes (8)
Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee
The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.
Measured: Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months
Patient Specific Anthropometrics
Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.
Measured: Collected at pre-op
American Knee Society (AKS) Score
AKS Score post-op at 12-months is reported for the final visit AKS score is a 0 -100-point scale with 100 being best knee condition.
Measured: Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval
KOOS Pain Sub-score
KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain activity of daily living, sports/recreation and quality of life. Further, the sub-score for pain is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up
Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs
KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain, activity of daily living, sports/recreation and quality of life. The score is a percentage score from 0 to 100 with 0 representing extreme problems and 100 representing no problems.
Measured: Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months
Patellar Crepitus Defined as No Crepitus, FINE or COARSE
Patellar Crepitus (grinding in the knee) analyzed and reported for pre-op, 6-months and 12-months and classified as No Crepitus, FINE or COARSE.
Measured: Collected at Pre-operative, 6 weeks and 6 and 12 months
Subject Satisfaction
Secondary objective to compare the pre-op goals and post-op satisfaction through the interpretation of data collected with the use of Palm technology for bilateral knee patients
Measured: Collected pre-and post-op, reported at 12-months
Single Leg Active Flexion (SLAF)
Weight-bearing single leg active flexion (SLAF). A medically trained professional conducts this test using a goniometer, which is an angle-measuring device. Of note, pre-op patients have a lower number because they were unable or unwilling to participate in SLAF due to pain.
Measured: Pre-op, 6- and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study start1 Mar 2006
- Primary completion1 Dec 2009
- Study completion1 Dec 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-inflammatory ArthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tammy O'Dell, EMT, CCRA, CCRC, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380861
- Sponsor's protocol ID
- 04092
- Status last verified
- Jul 2023
- First submitted
- 26 Sep 2006
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tippett SR, Mang J, Dwyer KA, Lesko J, O'Dell T. Collecting data with Palm technology: comparing preoperative expectations and postoperative satisfaction in patients undergoing total knee arthroplasty. J Bone Joint Surg Am. 2010 Dec;92 Suppl 2:59-67. doi: 10.2106/JBJS.J.00827. No abstract available.
PubMed 21123592
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Implant Design Improve Postoperative Flexion?A Prospective, Randomized, Comparative, Multi-center Study Comparing PFC® Sigma™ RP Knee Versus PFC® Sigma™ RP-F Implanted in Simultaneous Bilateral Subjects
- ClinicalTrials.gov ID
- NCT00380861
- Acronym / sponsor ID
- 04092
- Conditions
- Non-inflammatory Arthritis
- Keywords
- Total Knee Replacement, Flexion, Range of Motion, Activities of Daily Living, Implant design, Subject Satisfaction, Non-inflammatory arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2006 (actual)
- Primary completion
- 1 Dec 2009 (actual)
- Study completion
- 1 Dec 2009 (actual)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Posted 5 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day.
Detailed description
The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFC Sigma RP-F | Active comparator | Device: Total knee replacement using the PFC Sigma RPF knee implant.PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique. |
| PFC Sigma RP | Active comparator | Device: Total knee replacement using the PFC Sigma RP knee implantP.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a special insert that helps the knee move more like it did before the knee replacement. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non-Inflammatory Arthritis
- Age = 40-70 years
- Male or female
- Suitable for devices in study
- Needing primary simultaneous bilateral knee replacements
Key exclusion criteria (11 listed)
- Existing conditions that would compromise participation
- Multiple joint involvement
- Pregnant/lactating women
- Inflammatory arthritis
- Fixed flexion contracture greater than 20 degrees
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 replacement using the PFC Sigma RPF knee implant.Total knee replacement | Device | PFC Sigma RP-F |
| Total knee replacement using the PFC Sigma RP knee implantTotal knee replacement | Device | PFC Sigma RP |
Primary outcome
Knee Society Passive Flexion at 6 Months
Time frame: 6 months
The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.
8 secondary outcomes
Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee
Time frame: Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months
Patient Specific Anthropometrics
Time frame: Collected at pre-op
American Knee Society (AKS) Score
Time frame: Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval
KOOS Pain Sub-score
Time frame: Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up
Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs
Time frame: Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months
Patellar Crepitus Defined as No Crepitus, FINE or COARSE
Time frame: Collected at Pre-operative, 6 weeks and 6 and 12 months
Subject Satisfaction
Time frame: Collected pre-and post-op, reported at 12-months
Single Leg Active Flexion (SLAF)
Time frame: Pre-op, 6- and 12-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21123592Tippett SR, Mang J, Dwyer KA, Lesko J, O'Dell T. Collecting data with Palm technology: comparing preoperative expectations and postoperative satisfaction in patients undergoing total knee arthroplasty. J Bone Joint Surg Am. 2010 Dec;92 Suppl 2:59-67. doi: 10.2106/JBJS.J.00827. No abstract available.
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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 O'Dell, EMT, CCRA, CCRC study director
DePuy Orthopaedics
4 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 using the PFC Sigma RPF knee implant. and Total knee replacement using the PFC Sigma RP knee implant in people with Non-inflammatory Arthritis, run by DePuy Orthopaedics at 4 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 7 inclusion and 11 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 5 Apr 2011). 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 Passive Flexion at 6 Months (time frame: 6 months). 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 NCT00380861, 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 24 Jul 2023.