Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty
1 other identifier
interventional
938
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2005
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 7, 2006
CompletedFirst Posted
Study publicly available on registry
February 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
July 15, 2016
CompletedApril 24, 2017
March 1, 2017
8.2 years
February 7, 2006
May 30, 2014
March 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survivorship (Revision of Any Component for Any Reason)
Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.
5 years
Secondary Outcomes (8)
American Knee Society Evaluation - Total Score
2 year
American Knee Society Evaluation - Total Score
Minimum 5 years, up to 7.6 years
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
2 year
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)
Minimum 5 years, up to 7.6 years
- +3 more secondary outcomes
Study Arms (2)
GVF
ACTIVE COMPARATORGamma Vacuum Foil polyethylene tibial insert
P.F.C.
ACTIVE COMPARATORCross-linked polyethylene tibial insert
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Alabama Orthopaedic Clinic
Mobile, Alabama, 36608, United States
Pacific Bone and Joint Clinic
Berkley, California, 94705, United States
Orthopedic Center of the Rockies
Fort Collins, Colorado, 80525, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Jewett Orthopaedic Clinic
Orlando, Florida, 32817, United States
Jewett Orthopaedic Clinic
Winter Park, Florida, 32792, United States
Loyola University
Chicago, Illinois, 60153, United States
Rockford Orthopedic Associates
Rockford, Illinois, 61107, United States
Orthopaedic & Spine Specialists
York, Pennsylvania, 17402, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Serious adverse events were not collected in this study per the modern definition. All adverse events collected for this study will be reported in the 'Other Adverse Events' table. MedDRA was used to classify each AE into SOC, but not Preferred Term.
Results Point of Contact
- Title
- Clinical Portfolio Leader
- Organization
- DePuy Orthopaedics, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Gracia Etienne, MD
Orthopaedic & Spine Specialists
- PRINCIPAL INVESTIGATOR
Michael L. Granberry, MD
Alabama Orthopaedic Clinic
- PRINCIPAL INVESTIGATOR
Richard M. Konsens, MD
Jewett Orthopaedic Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2006
First Posted
February 9, 2006
Study Start
February 1, 2005
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
April 24, 2017
Results First Posted
July 15, 2016
Record last verified: 2017-03