Does Implant Design Improve Postoperative Flexion?
1 other identifier
interventional
93
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2006
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 26, 2006
CompletedFirst Posted
Study publicly available on registry
September 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
April 5, 2011
CompletedJuly 24, 2023
July 1, 2023
3.8 years
September 26, 2006
January 28, 2011
July 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
Collected at pre-op
American Knee Society (AKS) Score
Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval
KOOS Pain Sub-score
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
Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months
- +3 more secondary outcomes
Study Arms (2)
PFC Sigma RP-F
ACTIVE COMPARATORPFC® 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 COMPARATORP.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.
Interventions
Total knee replacement
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Doug Dennis
Denver, Colorado, 80210, United States
Heekin Orthopaedics
Jacksonville, Florida, 32204, United States
University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
Iowa City, Iowa, 01075, United States
Lakewood Orthopaedic Surgeons
Lakewood, Washington, 98499, United States
Related Publications (1)
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.
PMID: 21123592DERIVED
Results Point of Contact
- Title
- Tammy O'Dell
- Organization
- DePuy Orthopaedics
Study Officials
- STUDY DIRECTOR
Tammy O'Dell, EMT, CCRA, CCRC
DePuy Orthopaedics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2006
First Posted
September 27, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 24, 2023
Results First Posted
April 5, 2011
Record last verified: 2023-07