NCT00289133
Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
NA
COMPLETED
NCT00289133
INTERVENTIONAL
Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty
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.
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.
Osteoarthritis, Knee
Arthritis, Rheumatoid
- TREATMENT
-
- Type: DEVICE
- Name: total knee arthroplasty
- Description: Gamma Vacuum Foil polyethylene tibial insert
- Arm Group Labels: GVF
-
- Type: DEVICE
- Name: total knee arthroplasty
- Description: cross-linked polyethylene tibial insert
- Arm Group Labels: P.F.C.
- DePuy Orthopaedics