Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 938
Study Start Date: February 2005
Study Completion Date: May 2013
Primary Completion Date: May 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

Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 7, 2006
Results First Received: May 30, 2014
Last Updated: May 31, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by DePuy Orthopaedics:
Arthroplasty, Replacement, Knee

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

ClinicalTrials.gov processed this record on December 02, 2016