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Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs

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ClinicalTrials.gov Identifier: NCT00894361
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : May 7, 2009
Last Update Posted : July 30, 2013
Sponsor:
Collaborator:
Depuy, Inc.
Information provided by (Responsible Party):
Terence J. Gioe, M.D., Minneapolis Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE March 24, 2009
First Posted Date  ICMJE May 7, 2009
Results First Submitted Date  ICMJE March 24, 2009
Results First Posted Date  ICMJE May 7, 2009
Last Update Posted Date July 30, 2013
Study Start Date  ICMJE October 2001
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
Knee Postoperative Range of Motion (ROM) at 2 Years [ Time Frame: 2 years ]
range of motion of the knee postoperatively at 2 years
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2009)
Knee Postoperative ROM at 2 Years [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT00894361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2009)
Survival of the Implants to Subject Death or Implant Removal [ Time Frame: 10 or more years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
Official Title  ICMJE A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs
Brief Summary

This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:

  1. Does a RP design offer improvement in range of motion over a AP design?
  2. Does a RP design have improved wear characteristics over a nonmodular AP design?
  3. Is there a clear clinical advantage to the RP design that justifies its increased cost?

Answering these questions will allow surgeons to use RP designs appropriately in different demand populations.

This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Procedure: TKA surgery with the rotating platform mobile-bearing knee design
    Depuy Sigma RP rotating platform design
  • Procedure: TKA surgery with the all-polyethylene tibia knee design
    Depuy Sigma fixed-bearing design with all-polyethylene tibia
Study Arms  ICMJE
  • Active Comparator: rotating-platform design TKA
    patients who were randomized to receive the rotating platform mobile-bearing TKA design
    Intervention: Procedure: TKA surgery with the rotating platform mobile-bearing knee design
  • Active Comparator: all-polyethylene tibia design TKA
    patients who were randomized to receive the all-polyethylene tibial component design
    Intervention: Procedure: TKA surgery with the all-polyethylene tibia knee design
Publications * Gioe TJ, Glynn J, Sembrano J, Suthers K, Santos ER, Singh J. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs. A prospective randomized trial. J Bone Joint Surg Am. 2009 Sep;91(9):2104-12. doi: 10.2106/JBJS.H.01442.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2009)
400
Original Actual Enrollment  ICMJE
 (submitted: March 24, 2009)
312
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • generally accepted clinical and radiographic criteria for primary total knee arthroplasty

Exclusion Criteria:

  • substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
  • patients whose mental function precluded them from responding to our standard questionnaires
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00894361
Other Study ID Numbers  ICMJE MVA-3028
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Terence J. Gioe, M.D., Minneapolis Veterans Affairs Medical Center
Study Sponsor  ICMJE Minneapolis Veterans Affairs Medical Center
Collaborators  ICMJE Depuy, Inc.
Investigators  ICMJE
Principal Investigator: Terence J Gioe, M.D. Minneapolis VAMC, Dept. of Orthopaedic Surgery
PRS Account Minneapolis Veterans Affairs Medical Center
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP