At a glance
ClinicalIndex Comparison RecordN/ACompleted· 938 enrolled
Drug / intervention
total knee arthroplasty +1 moredevice
Likely dose
Not stated in record
Key inclusion· 4
- ✓Osteoarthritis of the knee appropriate for total knee arthroplasty
- ✓Diagnosis of rheumatoid arthritis, other inflammatory arthritis, post-traumatic arthritis, or juvenile rheumatoid arthritis
- ✓Adequate bone stock on imaging to support the prosthesis
- ✓Candidate for primary total knee replacement with the specified prosthesis
Key exclusion· 12
- ✕History of recent or active joint sepsis
- ✕Charcot neuropathy
- ✕Psycho-social disorders limiting rehabilitation capability
- ✕Pregnant or planning pregnancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty
In Brief
A clinical study evaluating total knee arthroplasty for Osteoarthritis, Knee and Arthritis, Rheumatoid. Completed, enrolled 938 participants across 9 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee, Arthritis, Rheumatoid
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2005
First PostedFeb 2006
Primary CompletionMay 2013
TodayJul 2026
First PostedFeb 9, 2006
Enrollment StartFeb 1, 2005
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 20.4 years ago
Interventions
total knee arthroplastydevice
Gamma Vacuum Foil polyethylene tibial insert
total knee arthroplastydevice
cross-linked polyethylene tibial insert