N/A
Completed N=938
Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
Osteoarthritis, Knee · Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00289133 ↗
Enrolled (actual)
938
Serious AEs
3.3%
Results posted
Jul 2016
Primary outcomePrimary: Survivorship (Revision of Any Component for Any Reason) — 96.8; 98.1 percentage of knees
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survivorship (Revision of Any Component for Any Reason) |
96.8; 98.1 | — |
| SECONDARY American Knee Society Evaluation - Total Score |
93.5; 93.1 | — |
| SECONDARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score |
11.0; 9.8 | — |
| SECONDARY Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm) |
9.5; 7.6 | — |
| SECONDARY Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm) |
0; 2.1 | — |
| SECONDARY Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm) |
0; 0 | — |
| SECONDARY Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm) |
2.0; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00289133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.