Does Implant Design Improve Postoperative Flexion?

Not Applicable

Completed

Conditions: Non-inflammatory Arthritis

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

Registration Number: NCT00380861

Lead Sponsor: DePuy Orthopaedics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 93

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFC Sigma RP-F	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	Total knee replacement using the PFC Sigma RP knee implant	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.

Primary Outcome Measures

Name	Time	Method
Knee Society Passive Flexion at 6 Months	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

Name	Time	Method
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	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	Collected at pre-op	Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.
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	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.
Single Leg Active Flexion (SLAF)	Pre-op, 6- and 12-months	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.
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	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	Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up	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.
Patellar Crepitus Defined as No Crepitus, FINE or COARSE	Collected at Pre-operative, 6 weeks and 6 and 12 months	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	Collected pre-and post-op, reported at 12-months	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

Trial Locations

Locations (4): Doug Dennis
🇺🇸
Denver, Colorado, United States
Heekin Orthopaedics
🇺🇸
Jacksonville, Florida, United States
Lakewood Orthopaedic Surgeons
🇺🇸
Lakewood, Washington, United States
University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
🇺🇸
Iowa City, Iowa, United States