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

Osteoarthritis, Knee Clinical Trial

Official title:

Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00289133
• Other study ID #: 03111
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 7, 2006
• Last updated: April 3, 2013
• Start date: February 2005
• Est. completion date: May 2013

Study information

• Verified date: April 2013
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 937
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Osteoarthritis, Knee

Intervention

Other:
• total knee arthroplasty
Gamma Vacuum Foil polyethylene tibial bearing component

Device:
• total knee arthroplasty
cross-linked polyethylene tibial bearing component

Locations

Country	Name	City	State
United States	Pacific Bone and Joint Clinic	Berkley	California
United States	Loyola University	Chicago	Illinois
United States	Orthopedic Center of the Rockies	Fort Collins	Colorado
United States	Holy Cross Hospital	Ft. Lauderdale	Florida
United States	Alabama Orthopaedic Clinic	Mobile	Alabama
United States	Jewett Orthopaedic Clinic	Orlando	Florida
United States	Rockford Orthopedic Associates	Rockford	Illinois
United States	Jewett Orthopaedic Clinic	Winter Park	Florida
United States	Orthopaedic & Spine Specialists	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship		5 years	Yes
Secondary	American Knee Society scores		2 years and 5 years	No
Secondary	Medical imaging		5 years	Yes