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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289133
First Posted: February 9, 2006
Last Update Posted: April 24, 2017
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.
Information provided by (Responsible Party):
DePuy Orthopaedics
  Purpose
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.

Condition Intervention
Osteoarthritis, Knee Arthritis, Rheumatoid Device: total knee arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 938
Actual Study Start Date: February 1, 2005
Study Completion Date: May 1, 2013
Primary Completion Date: May 1, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GVF
Gamma Vacuum Foil polyethylene tibial insert
Device: total knee arthroplasty
Gamma Vacuum Foil polyethylene tibial insert
Active Comparator: P.F.C.
Cross-linked polyethylene tibial insert
Device: total knee arthroplasty
cross-linked polyethylene tibial insert
Other Name: P.F.C. Sigma cross-linked bearing

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289133


Locations
United States, Alabama
Alabama Orthopaedic Clinic
Mobile, Alabama, United States, 36608
United States, California
Pacific Bone and Joint Clinic
Berkley, California, United States, 94705
United States, Colorado
Orthopedic Center of the Rockies
Fort Collins, Colorado, United States, 80525
United States, Florida
Holy Cross Hospital
Ft. Lauderdale, Florida, United States, 33308
Jewett Orthopaedic Clinic
Orlando, Florida, United States, 32817
Jewett Orthopaedic Clinic
Winter Park, Florida, United States, 32792
United States, Illinois
Loyola University
Chicago, Illinois, United States, 60153
Rockford Orthopedic Associates
Rockford, Illinois, United States, 61107
United States, Pennsylvania
Orthopaedic & Spine Specialists
York, Pennsylvania, United States, 17402
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
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
  More Information

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00289133     History of Changes
Other Study ID Numbers: 03111
First Submitted: February 7, 2006
First Posted: February 9, 2006
Results First Submitted: May 30, 2014
Results First Posted: July 15, 2016
Last Update Posted: April 24, 2017
Last Verified: March 2017

Keywords provided by DePuy Orthopaedics:
Arthroplasty, Replacement, Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases