Status:
COMPLETED
Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
Lead Sponsor:
DePuy Orthopaedics
Conditions:
Osteoarthritis, Knee
Arthritis, Rheumatoid
Eligibility:
All Genders
Up to 80 years
Phase:
NA
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 pac...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
938 Patients enrolled
Trial Details
Trial ID
NCT00289133
Start Date
February 1 2005
End Date
May 1 2013
Last Update
April 24 2017
Active Locations (9)
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1
Alabama Orthopaedic Clinic
Mobile, Alabama, United States, 36608
2
Pacific Bone and Joint Clinic
Berkley, California, United States, 94705
3
Orthopedic Center of the Rockies
Fort Collins, Colorado, United States, 80525
4
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308