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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid; Osteoarthritis, Knee
• Intervention / Treatment: Device: total knee arthroplasty; Device: 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: Interventional
• Enrollment (Actual): 938
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GVF; Gamma Vacuum Foil polyethylene tibial insert	Device: total knee arthroplasty; Gamma Vacuum Foil polyethylene tibial insert; Device: total knee arthroplasty; cross-linked polyethylene tibial insert; Other Names: P.F.C. Sigma cross-linked bearing
Active Comparator: P.F.C.; Cross-linked polyethylene tibial insert	Device: total knee arthroplasty; Gamma Vacuum Foil polyethylene tibial insert; Device: total knee arthroplasty; cross-linked polyethylene tibial insert; Other Names: P.F.C. Sigma cross-linked bearing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship (Revision of Any Component for Any Reason)	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Knee Society Evaluation - Total Score	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.	2 year
American Knee Society Evaluation - Total Score	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.	Minimum 5 years, up to 7.6 years
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score	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.	2 year
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score	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.	Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)		Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)		Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)		Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)		Minimum 5 years, up to 7.6 years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2005
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 7, 2006
• First Submitted That Met QC Criteria: February 7, 2006
• First Posted (Estimate): February 9, 2006

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Arthroplasty, Replacement, Knee
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Osteoarthritis, Knee
• Other Study ID Numbers: 03111