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Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00289133
Recruitment Status : Completed
First Posted : February 9, 2006
Results First Posted : July 15, 2016
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 9, 2006
Results First Submitted Date  ICMJE May 30, 2014
Results First Posted Date  ICMJE July 15, 2016
Last Update Posted Date April 24, 2017
Actual Study Start Date  ICMJE February 1, 2005
Actual Primary Completion Date May 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
Survivorship (Revision of Any Component for Any Reason) [ Time Frame: 5 years ]
Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
Survivorship
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • American Knee Society Evaluation - Total Score [ Time Frame: 2 year ]
    American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
  • American Knee Society Evaluation - Total Score [ Time Frame: Minimum 5 years, up to 7.6 years ]
    American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score [ Time Frame: 2 year ]
    WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score [ Time Frame: Minimum 5 years, up to 7.6 years ]
    WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.
  • Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm) [ Time Frame: Minimum 5 years, up to 7.6 years ]
  • Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm) [ Time Frame: Minimum 5 years, up to 7.6 years ]
  • Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm) [ Time Frame: Minimum 5 years, up to 7.6 years ]
  • Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm) [ Time Frame: Minimum 5 years, up to 7.6 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
  • American Knee Society scores
  • Radiographic evaluation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
Official Title  ICMJE Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty
Brief Summary The purpose of this study is to evaluate long-term clinical and radiographic data between geometrically identical GVF and cross-linked polyethylene-bearing inserts in total knee arthroplasty.
Detailed Description

In 1996, Gamma Vacuum Foil (GVF) polyethylene was introduced as the first polyethylene to be gamma irradiated and packaged in an inert environment. This polyethylene, with its patented process and packaging, continues to be the only barrier-packaged process that is impermeable to both Hydrogen (H2) and Oxygen (O2), and allows the polyethylene to recombine and cross-link in the package. Though the new moderately cross-linked polyethylene being evaluated in this protocol is comparable to GVF geometrically and mechanically, the P.F.C.® Sigma™ cross-linked polyethylene also has the added benefit of being completely oxidatively stable both on the shelf and in-vivo.

The P.F.C. Sigma tibial tray component being assessed in this study is made of Cobalt Chrome (CoCr). The new CoCr tibial tray has the same design geometrically as the original titanium (Ti) tray, however, it features a highly polished top surface where it is joined to the polyethylene. This polished surface is designed to decrease the coefficient of friction between the polyethylene and the tray, thus minimizing backside wear. A comparative clinical study will be conducted to evaluate long-term clinical and radiographic data between geometrically identical cemented implants using GVF and crosslinked polyethylene tibial tray bearing inserts in Total Knee Arthroplasty (TKA) using the P.F.C. Sigma Total Knee System. Patients will be assigned to study treatment groups at random if they meet specific demographic and pathophysiologic criteria for cemented total knee arthroplasty. The anticipated duration of this investigation is a minimum six years, which includes a one-year enrollment phase.

The specific aims of this study are as follows:

  1. Examine whether crosslinked polyethylene performs as well, if not better, than GVF polyethylene through standard clinical evaluations.
  2. Evaluate long-term survivorship rates.
  3. Report complications/adverse events.
  4. Report radiographic findings of geometrically identical implants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Arthritis, Rheumatoid
Intervention  ICMJE
  • Device: total knee arthroplasty
    Gamma Vacuum Foil polyethylene tibial insert
  • Device: total knee arthroplasty
    cross-linked polyethylene tibial insert
    Other Name: P.F.C. Sigma cross-linked bearing
Study Arms  ICMJE
  • Active Comparator: GVF
    Gamma Vacuum Foil polyethylene tibial insert
    Intervention: Device: total knee arthroplasty
  • Active Comparator: P.F.C.
    Cross-linked polyethylene tibial insert
    Intervention: Device: total knee arthroplasty
Publications * Not Provided

*   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 31, 2016)
938
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 1, 2013
Actual Primary Completion Date May 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Osteoarthritis of the affected joint appropriate for Total Knee Arthroplasty.
  2. Diagnosis of any of the following: rheumatoid or other inflammatory arthritis, post-traumatic arthritis, juvenile rheumatoid arthritis.
  3. Radiographic evidence of sufficient sound bone stock to seat and support the prosthesis.
  4. Subject requires a primary total knee replacement and is considered to be suitable for the specific knee prosthesis identified in protocol.
  5. Subject has given consent to the transfer of his/her information to sponsor.
  6. Subject will be compliant with requirements of protocol by returning for follow-up visits.

Exclusion Criteria:

  1. History of recent/active joint sepsis.
  2. Charcot neuropathy.
  3. Psycho-social disorders that would limit rehabilitation.
  4. Women who are pregnant or planning on being pregnant.
  5. Greater than 80 years of age at the time of surgery.
  6. Prior ipsilateral knee arthroplasty.
  7. Metabolic disorders of calcified tissues, such as Paget's disease.
  8. Severe diabetes mellitus that is not controlled by diet or oral agents.
  9. Require joint replacement due to immunodeficiency syndromes.
  10. Skeletal immaturity.
  11. Avascular necrosis of the affected knee.
  12. Chronic renal disease.
  13. Subjects involved in medical-legal or worker's compensation claims.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00289133
Other Study ID Numbers  ICMJE 03111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DePuy Orthopaedics
Study Sponsor  ICMJE DePuy Orthopaedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gracia Etienne, MD Orthopaedic & Spine Specialists
Principal Investigator: Michael L. Granberry, MD Alabama Orthopaedic Clinic
Principal Investigator: Richard M. Konsens, MD Jewett Orthopaedic Clinic
PRS Account DePuy Orthopaedics
Verification Date March 2017

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