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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00289133
First received: February 7, 2006
Last updated: April 3, 2013
Last verified: April 2013

February 7, 2006
April 3, 2013
February 2005
May 2013   (final data collection date for primary outcome measure)
Survivorship [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Survivorship
Complete list of historical versions of study NCT00289133 on ClinicalTrials.gov Archive Site
  • American Knee Society scores [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
  • Medical imaging [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • American Knee Society scores
  • Radiographic evaluation
Not Provided
Not Provided
 
Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis, Knee
  • Arthritis, Rheumatoid
  • Other: total knee arthroplasty
    Gamma Vacuum Foil polyethylene tibial bearing component
  • Device: total knee arthroplasty
    cross-linked polyethylene tibial bearing component
    Other Name: P.F.C. Sigma cross-linked bearing
  • Active Comparator: A
    Gamma Vacuum Foil polyethylene tibial component
    Intervention: Other: total knee arthroplasty
  • Active Comparator: B
    Cross-linked polyethylene tibial component
    Intervention: Device: total knee arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
937
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00289133
03111
No
DePuy Orthopaedics
DePuy Orthopaedics
Not Provided
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
DePuy Orthopaedics
April 2013

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