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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee; Arthritis, Rheumatoid
• Interventions: Device: total knee arthroplasty

• Registration Number: NCT00289133
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

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.

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 Timeline

• Study Start: 2005-02-01
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-09
• Primary Completion: 2013-05-01
• Study Completion: 2013-05-01
• Results First Submitted: 2014-05-30
• Results First Submitted QC: 2016-05-31
• Results First Posted: 2016-07-15
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 938

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P.F.C.	total knee arthroplasty	Cross-linked polyethylene tibial insert
GVF	total knee arthroplasty	Gamma Vacuum Foil polyethylene tibial insert

Primary Outcome Measures

Name	Time	Method
Survivorship (Revision of Any Component for Any Reason)	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

Name	Time	Method
American Knee Society Evaluation - Total Score	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	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)	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

Trial Locations

Locations (8)

Alabama Orthopaedic Clinic; 🇺🇸 Mobile, Alabama, United States

Jewett Orthopaedic Clinic; 🇺🇸 Winter Park, Florida, United States

Pacific Bone and Joint Clinic; 🇺🇸 Berkley, California, United States

Holy Cross Hospital; 🇺🇸 Ft. Lauderdale, Florida, United States

Loyola University; 🇺🇸 Chicago, Illinois, United States

Rockford Orthopedic Associates; 🇺🇸 Rockford, Illinois, United States

Orthopaedic & Spine Specialists; 🇺🇸 York, Pennsylvania, United States

Orthopedic Center of the Rockies; 🇺🇸 Fort Collins, Colorado, United States