Does Implant Design Improve Postoperative Flexion?

Non-inflammatory Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380861
• Other study ID #: 04092
• Status: Completed
• Phase: N/A
• Start date: March 1, 2006
• Est. completion date: December 1, 2009

Study information

• Verified date: July 2023
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 1, 2009
• Est. primary completion date: December 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Non-inflammatory Arthritis

Intervention

Device:
• Total knee replacement using the PFC Sigma RPF knee implant.
Total knee replacement
• Total knee replacement using the PFC Sigma RP knee implant
Total knee replacement

Locations

Country	Name	City	State
United States	Doug Dennis	Denver	Colorado
United States	University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery	Iowa City	Iowa
United States	Heekin Orthopaedics	Jacksonville	Florida
United States	Lakewood Orthopaedic Surgeons	Lakewood	Washington

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months
Secondary	Patient Specific Anthropometrics	Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.	Collected at pre-op
Secondary	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.	Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval
Secondary	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.	Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up
Secondary	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.	Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months
Secondary	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.	Collected at Pre-operative, 6 weeks and 6 and 12 months
Secondary	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	Collected pre-and post-op, reported at 12-months
Secondary	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.	Pre-op, 6- and 12-months