Does Implant Design Improve Postoperative Flexion?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00380861
First received: September 26, 2006
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Non-inflammatory Arthritis
Device: Total knee replacement using the PFC Sigma RPF knee implant.
Device: Total knee replacement using the PFC Sigma RP knee implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Knee Society Passive Flexion at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Single Leg Passive Flexion at All Scheduled Follow-up Visits: 2 Weeks, 6 Weeks, 6 Months and 12 Months. [ Time Frame: Pre-operative, 2 and 6 weeks and 6 and 12 months follow up ] [ Designated as safety issue: No ]
  • Effect of Subject Demographics and Anthropometrics on ROM [ Time Frame: Pre-operative, 2 and 6 weeks and 6 and 12 months follow up ] [ Designated as safety issue: No ]
  • AKS Score [ Time Frame: Pre-operative, 2 and 6 weeks and 6 and 12 months follow up ] [ Designated as safety issue: No ]
  • KOOS Score [ Time Frame: Pre-operative, 2 and 6 weeks and 6 and 12 months follow up ] [ Designated as safety issue: No ]
  • Knee Pain [ Time Frame: Pre-operative, 2 and 6 weeks and 6 and 12 months follow up ] [ Designated as safety issue: No ]
  • Ability to Perform Activities [ Time Frame: Pre-operative, 2 and 6 weeks and 6 and 12 months follow up ] [ Designated as safety issue: No ]
  • Crepitus [ Time Frame: Pre-operative, 2 and 6 weeks and 6 and 12 months follow up ] [ Designated as safety issue: Yes ]
  • Subject Satisfaction [ Time Frame: Pre-operative, 2 and 6 weeks and 6 and 12 months follow up ] [ Designated as safety issue: No ]
  • Single Leg Active Flexion at 2 Weeks, 6 Weeks, 6 Months and 12 Months. [ Time Frame: 2 weeks, 6 weeks, 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: March 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PFC Sigma RP-F
PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique.
Device: Total knee replacement using the PFC Sigma RPF knee implant.
Total knee replacement
Active Comparator: PFC Sigma RP
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.
Device: Total knee replacement using the PFC Sigma RP knee implant
Total knee replacement

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380861

Locations
United States, Colorado
Doug Dennis
Denver, Colorado, United States, 80210
United States, Florida
Heekin Orthopaedics
Jacksonville, Florida, United States, 32204
United States, Iowa
University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
Iowa City, Iowa, United States, 01075
United States, Washington
Lakewood Orthopaedic Surgeons
Lakewood, Washington, United States, 98499
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Tammy O'Dell, EMT, CCRA, CCRC DePuy Orthopaedics
  More Information

No publications provided by DePuy Orthopaedics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00380861     History of Changes
Other Study ID Numbers: 04092
Study First Received: September 26, 2006
Results First Received: January 28, 2011
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by DePuy Orthopaedics:
Total Knee Replacement
Flexion
Range of Motion
Activities of Daily Living
Implant design
Subject Satisfaction
Non-inflammatory arthritis

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014