Clinical trial NCT00289133: Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
Official title: Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Arthritis, Rheumatoid
Keywords: Arthroplasty, Replacement, Knee
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 938
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Survivorship (Revision of Any Component for Any Reason)
timeFrame: 5 years
Secondary outcomes:
measure: American Knee Society Evaluation - Total Score
timeFrame: 2 year
measure: American Knee Society Evaluation - Total Score
timeFrame: Minimum 5 years, up to 7.6 years
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
timeFrame: 2 year
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
timeFrame: Minimum 5 years, up to 7.6 years
measure: Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)
timeFrame: Minimum 5 years, up to 7.6 years
measure: Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)
timeFrame: Minimum 5 years, up to 7.6 years
measure: Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)
timeFrame: Minimum 5 years, up to 7.6 years
measure: Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)
timeFrame: Minimum 5 years, up to 7.6 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Alabama Orthopaedic Clinic
state: Alabama
city: Berkley
country: United States
facility: Pacific Bone and Joint Clinic
state: California
city: Fort Collins
country: United States
facility: Orthopedic Center of the Rockies
state: Colorado
city: Ft. Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Orlando
country: United States
facility: Jewett Orthopaedic Clinic
state: Florida
city: Winter Park
country: United States
facility: Jewett Orthopaedic Clinic
state: Florida
city: Chicago
country: United States
facility: Loyola University
state: Illinois
city: Rockford
country: United States
facility: Rockford Orthopedic Associates
state: Illinois
city: York
country: United States
facility: Orthopaedic & Spine Specialists
state: Pennsylvania
Study officials:
affiliation: Orthopaedic & Spine Specialists
name: Gracia Etienne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alabama Orthopaedic Clinic
name: Michael L. Granberry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jewett Orthopaedic Clinic
name: Richard M. Konsens, MD
role: PRINCIPAL_INVESTIGATOR
References: