Back to resultsDoes Implant Design Improve Postoperative Flexion?
Primary Purpose
Non-inflammatory Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total knee replacement using the PFC Sigma RPF knee implant.
Total knee replacement using the PFC Sigma RP knee implant
Sponsored by
About this trial
This is an interventional treatment trial for Non-inflammatory Arthritis focused on measuring Total Knee Replacement, Flexion, Range of Motion, Activities of Daily Living, Implant design, Subject Satisfaction, Non-inflammatory arthritis
Eligibility Criteria
Inclusion Criteria:
- 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,
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Doug Dennis
- Heekin Orthopaedics
- University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
- Lakewood Orthopaedic Surgeons
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PFC Sigma RP-F
PFC Sigma RP
Arm Description
PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Patient Specific Anthropometrics
Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.
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.
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.
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.
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00380861
Brief Title
Does Implant Design Improve Postoperative Flexion?
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2006 (Actual)
Primary Completion Date
December 1, 2009 (Actual)
Study Completion Date
December 1, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-inflammatory Arthritis
Keywords
Total Knee Replacement, Flexion, Range of Motion, Activities of Daily Living, Implant design, Subject Satisfaction, Non-inflammatory arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PFC Sigma RP-F
Arm Type
Active Comparator
Arm Description
PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique.
Arm Title
PFC Sigma RP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Total knee replacement using the PFC Sigma RPF knee implant.
Intervention Description
Total knee replacement
Intervention Type
Device
Intervention Name(s)
Total knee replacement using the PFC Sigma RP knee implant
Intervention Description
Total knee replacement
Primary Outcome Measure Information:
Title
Knee Society Passive Flexion at 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Description
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.
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
Title
Patient Specific Anthropometrics
Description
Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.
Time Frame
Collected at pre-op
Title
American Knee Society (AKS) Score
Description
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.
Time Frame
Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval
Title
KOOS Pain Sub-score
Description
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.
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
Title
Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs
Description
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.
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
Title
Patellar Crepitus Defined as No Crepitus, FINE or COARSE
Description
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.
Time Frame
Collected at Pre-operative, 6 weeks and 6 and 12 months
Title
Subject Satisfaction
Description
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
Time Frame
Collected pre-and post-op, reported at 12-months
Title
Single Leg Active Flexion (SLAF)
Description
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.
Time Frame
Pre-op, 6- and 12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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,
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy O'Dell, EMT, CCRA, CCRC
Organizational Affiliation
DePuy Orthopaedics
Official's Role
Study Director
Facility Information:
Facility Name
Doug Dennis
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Heekin Orthopaedics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
01075
Country
United States
Facility Name
Lakewood Orthopaedic Surgeons
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21123592
Citation
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.
Results Reference
derived
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Does Implant Design Improve Postoperative Flexion?
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