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

Completed · Not applicable

Conditions studied: Osteoarthritis, Knee, Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT00289133

Run by

DePuy Orthopaedics

People needed

938

Starts

2005-02-01

Expected to finish

2013-05-01

Last updated by the study team

2017-04-24

Who can join

Age: any, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Osteoarthritis of the affected joint appropriate for Total Knee Arthroplasty.
• Diagnosis of any of the following: rheumatoid or other inflammatory arthritis, post-traumatic arthritis, juvenile rheumatoid arthritis.
• Radiographic evidence of sufficient sound bone stock to seat and support the prosthesis.
• Subject requires a primary total knee replacement and is considered to be suitable for the specific knee prosthesis identified in protocol.
• Subject has given consent to the transfer of his/her information to sponsor.
• Subject will be compliant with requirements of protocol by returning for follow-up visits.

You may not qualify if…

• History of recent/active joint sepsis.
• Charcot neuropathy.
• Psycho-social disorders that would limit rehabilitation.
• Women who are pregnant or planning on being pregnant.
• Greater than 80 years of age at the time of surgery.
• Prior ipsilateral knee arthroplasty.
• Metabolic disorders of calcified tissues, such as Paget's disease.
• Severe diabetes mellitus that is not controlled by diet or oral agents.
• Require joint replacement due to immunodeficiency syndromes.
• Skeletal immaturity.
• Avascular necrosis of the affected knee.
• Chronic renal disease.
• Subjects involved in medical-legal or worker's compensation claims.

Where it is running

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

Full record on ClinicalTrials.gov

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