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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014