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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00289133
First received: February 7, 2006
Last updated: May 31, 2016
Last verified: May 2016

February 7, 2006
May 31, 2016
February 2005
May 2013   (final data collection date for primary outcome measure)
Survivorship (Revision of Any Component for Any Reason) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
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.
Survivorship
Complete list of historical versions of study NCT00289133 on ClinicalTrials.gov Archive Site
  • American Knee Society Evaluation - Total Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 max total score is 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 ] [ Designated as safety issue: No ]
    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 max total score is 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 ] [ Designated as safety issue: Yes ]
  • Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm) [ Time Frame: Minimum 5 years, up to 7.6 years ] [ Designated as safety issue: Yes ]
  • Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm) [ Time Frame: Minimum 5 years, up to 7.6 years ] [ Designated as safety issue: Yes ]
  • Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm) [ Time Frame: Minimum 5 years, up to 7.6 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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis, Knee
  • Arthritis, Rheumatoid
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
938
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
up to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00289133
03111
No
Not Provided
Not Provided
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
May 2016

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