Osteoarthritis, KneeNCT00289133
Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
A study testing total knee arthroplasty in people with Osteoarthritis, Knee and Arthritis, Rheumatoid, run by DePuy Orthopaedics at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Arthritis, Rheumatoid
- What is being tested?
- total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 938 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Feb 2005to 1 May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Pacific Bone and Joint Clinic
Berkley, California, 94705
Loyola University
Chicago, Illinois, 60153
Orthopedic Center of the Rockies
Fort Collins, Colorado, 80525
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Alabama Orthopaedic Clinic
Mobile, Alabama, 36608
Jewett Orthopaedic Clinic
Orlando, Florida, 32817
Rockford Orthopedic Associates
Rockford, Illinois, 61107
Jewett Orthopaedic Clinic
Winter Park, Florida, 32792
Orthopaedic & Spine Specialists
York, Pennsylvania, 17402
About this study
Official title: 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.
Read the 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 packaging, continues to be the only barrier-packaged process that is impermeable to both Hydrogen (H2) and Oxygen (O2), and allows the polyethylene to recombine and cross-link in the package. Though the new moderately cross-linked polyethylene being evaluated in this protocol is comparable to GVF geometrically and mechanically, the P.F.C.® Sigma™ cross-linked polyethylene also has the added benefit of being completely oxidatively stable both on the shelf and in-vivo.
The P.F.C. Sigma tibial tray component being assessed in this study is made of Cobalt Chrome (CoCr). The new CoCr tibial tray has the same design geometrically as the original titanium (Ti) tray, however, it features a highly polished top surface where it is joined to the polyethylene. This polished surface is designed to decrease the coefficient of friction between the polyethylene and the tray, thus minimizing backside wear. A comparative clinical study will be conducted to evaluate long-term clinical and radiographic data between geometrically identical cemented implants using GVF and crosslinked polyethylene tibial tray bearing inserts in Total Knee Arthroplasty (TKA) using the P.F.C. Sigma Total Knee System. Patients will be assigned to study treatment groups at random if they meet specific demographic and pathophysiologic criteria for cemented total knee arthroplasty. The anticipated duration of this investigation is a minimum six years, which includes a one-year enrollment phase.
The specific aims of this study are as follows:
- Examine whether crosslinked polyethylene performs as well, if not better, than GVF polyethylene through standard clinical evaluations.
- Evaluate long-term survivorship rates.
- Report complications/adverse events.
- Report radiographic findings of geometrically identical implants.
- Conditions
- Osteoarthritis, Knee, Arthritis, Rheumatoid
- Being tested
- total knee arthroplasty
- Keywords
- Arthroplasty, Replacement, Knee
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyDevice
Gamma Vacuum Foil polyethylene tibial insert
total knee arthroplastyDevice
Also called P.F.C. Sigma cross-linked bearing
cross-linked polyethylene tibial insert
| Study group | Role | What they receive |
|---|---|---|
| GVF | Active comparator | Gamma Vacuum Foil polyethylene tibial insert Receives: Device: total knee arthroplasty |
| P.F.C. | Active comparator | Cross-linked polyethylene tibial insert Receives: Device: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (8)
American Knee Society Evaluation - Total Score
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Measured: 2 year
American Knee Society Evaluation - Total Score
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Measured: Minimum 5 years, up to 7.6 years
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.
Measured: 2 year
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.
Measured: Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)
Measured: Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)
Measured: Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)
Measured: Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)
Measured: Minimum 5 years, up to 7.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study start1 Feb 2005
- Primary completion1 May 2013
- Study completion1 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 938 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gracia Etienne, MD, Principal investigator, Orthopaedic & Spine SpecialistsMichael L. Granberry, MD, Principal investigator, Alabama Orthopaedic ClinicRichard M. Konsens, MD, Principal investigator, Jewett Orthopaedic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289133
- Sponsor's protocol ID
- 03111
- Status last verified
- Mar 2017
- First submitted
- 7 Feb 2006
- Last updated
- 24 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00289133
- Acronym / sponsor ID
- 03111
- Conditions
- Osteoarthritis, Knee, Arthritis, Rheumatoid
- Keywords
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 938 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2005 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 May 2013 (actual)
- First posted
- 9 Feb 2006 (estimated)
- Results
- Posted 15 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 packaging, continues to be the only barrier-packaged process that is impermeable to both Hydrogen (H2) and Oxygen (O2), and allows the polyethylene to recombine and cross-link in the package. Though the new moderately cross-linked polyethylene being evaluated in this protocol is comparable to GVF geometrically and mechanically, the P.F.C.® Sigma™ cross-linked polyethylene also has the added benefit of being completely oxidatively stable both on the shelf and in-vivo.
The P.F.C. Sigma tibial tray component being assessed in this study is made of Cobalt Chrome (CoCr). The new CoCr tibial tray has the same design geometrically as the original titanium (Ti) tray, however, it features a highly polished top surface where it is joined to the polyethylene. This polished surface is designed to decrease the coefficient of friction between the polyethylene and the tray, thus minimizing backside wear. A comparative clinical study will be conducted to evaluate long-term clinical and radiographic data between geometrically identical cemented implants using GVF and crosslinked polyethylene tibial tray bearing inserts in Total Knee Arthroplasty (TKA) using the P.F.C. Sigma Total Knee System. Patients will be assigned to study treatment groups at random if they meet specific demographic and pathophysiologic criteria for cemented total knee arthroplasty. The anticipated duration of this investigation is a minimum six years, which includes a one-year enrollment phase.
The specific aims of this study are as follows:
- Examine whether crosslinked polyethylene performs as well, if not better, than GVF polyethylene through standard clinical evaluations.
- Evaluate long-term survivorship rates.
- Report complications/adverse events.
- Report radiographic findings of geometrically identical implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GVF | Active comparator | Device: total knee arthroplastyGamma Vacuum Foil polyethylene tibial insert |
| P.F.C. | Active comparator | Device: total knee arthroplastyCross-linked polyethylene tibial insert |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total knee arthroplastyGamma Vacuum Foil polyethylene tibial insert | Device | GVF |
| total knee arthroplastyAlso: P.F.C. Sigma cross-linked bearingcross-linked polyethylene tibial insert | Device | P.F.C. |
Primary outcome
Survivorship (Revision of Any Component for Any Reason)
Time frame: 5 years
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.
8 secondary outcomes
American Knee Society Evaluation - Total Score
Time frame: 2 year
American Knee Society Evaluation - Total Score
Time frame: Minimum 5 years, up to 7.6 years
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
Time frame: 2 year
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
Time frame: Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)
Time frame: Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)
Time frame: Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)
Time frame: Minimum 5 years, up to 7.6 years
Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)
Time frame: Minimum 5 years, up to 7.6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gracia Etienne, MD principal investigator
Orthopaedic & Spine Specialists
Michael L. Granberry, MD principal investigator
Alabama Orthopaedic Clinic
Richard M. Konsens, MD principal investigator
Jewett Orthopaedic Clinic
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total knee arthroplasty in people with Osteoarthritis, Knee and Arthritis, Rheumatoid, run by DePuy Orthopaedics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship (Revision of Any Component for Any Reason) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.