CompletedNCT00289133Updated Apr 24, 2017Results posted

Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study

An interventional study of total knee arthroplasty and total knee arthroplasty in Osteoarthritis, Knee and Arthritis, Rheumatoid, sponsored by DePuy Orthopaedics. Completed at 9 sites in United States. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-24.

Sponsored by DePuy Orthopaedics (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year after the study started (first participant enrolled Feb 2005, registered Feb 2006).

Phase: Not applicable
Study type: Interventional
Enrollment: 938
Allocation: Randomized
Ages: Up to 80 Years
Sex: All

Study 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 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 studied

Osteoarthritis, Knee
Arthritis, Rheumatoid

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Keywords

Arthroplasty, Replacement, Knee

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 938 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

DePuy Orthopaedics is the lead sponsor of 45 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

First submitted after DePuy Orthopaedics became part of Johnson & Johnson.

Browse DePuy Orthopaedics studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 938 participants (actual)

Study arms

Active comparator
GVF
Gamma Vacuum Foil polyethylene tibial insert
Device: total knee arthroplasty
Active comparator
P.F.C.
Cross-linked polyethylene tibial insert
Device: total knee arthroplasty

Interventions

Devicetotal knee arthroplasty
Gamma Vacuum Foil polyethylene tibial insert
Devicetotal knee arthroplasty
cross-linked polyethylene tibial insert
Also known as: P.F.C. Sigma cross-linked bearing

What researchers measure

Primary outcomes

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.
Time frame: 5 years

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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

Posted Jul 15, 2016

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.

Participant flow

Participant flow — Overall Study
Milestone	GVF Poly	XLK Poly
Started	461	477
Completed	189	179
Not completed	272	298
Withdrew: Non-study device implanted	12	0
Withdrew: Protocol violation	32	38
Withdrew: Withdrawal by subject	9	10
Withdrew: Death	5	10
Withdrew: Lost to follow-up - hurricane katri	73	74
Withdrew: Physician decision	41	45
Withdrew: Revision	8	6
Withdrew: Lost to follow-up	92	115

Outcome measures

PrimarySurvivorship (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.

Time frame:: 5 years
Reported as:: Number · percentage of knees

Survivorship (Revision of Any Component for Any Reason)
percentage of knees	GVF Poly	XLK Poly
Survivorship (Revision of Any Component for Any Reason)	96.8 (93.9 to 98.4)	98.1 (95.6 to 99.2)

SecondaryAmerican 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.

Time frame:: 2 year
Reported as:: Mean · scores on a scale

American Knee Society Evaluation - Total Score
scores on a scale	GVF Poly	XLK Poly
American Knee Society Evaluation - Total Score	94.7 ± 7.9	93.5 ± 9.5

SecondaryAmerican Knee Society Evaluation - Total Score

Time frame:: Minimum 5 years, up to 7.6 years
Reported as:: Mean · scores on a scale

American Knee Society Evaluation - Total Score
scores on a scale	GVF Poly	XLK Poly
American Knee Society Evaluation - Total Score	93.5 ± 9.2	93.1 ± 8.5

SecondaryWestern 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.

Time frame:: 2 year
Reported as:: Mean · scores (points) on a scale

Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
scores (points) on a scale	GVF Poly	XLK Poly
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score	10.2 ± 13.4	11.5 ± 15.3

SecondaryWestern Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score

Time frame:: Minimum 5 years, up to 7.6 years
Reported as:: Mean · scores (points) on a scale

Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
scores (points) on a scale	GVF Poly	XLK Poly
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score	11.0 ± 14.1	9.8 ± 13.2

SecondaryRadiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)

Time frame:: Minimum 5 years, up to 7.6 years
Reported as:: Number · percentage of knees

Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)
percentage of knees	GVF Poly	XLK Poly
Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)	9.5	7.6

SecondaryRadiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)

Time frame:: Minimum 5 years, up to 7.6 years
Reported as:: Number · percentage of knees

Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)
percentage of knees	GVF Poly	XLK Poly
Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)	0	2.1

SecondaryRadiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)

Time frame:: Minimum 5 years, up to 7.6 years
Reported as:: Number · percentage of knees

Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)
percentage of knees	GVF Poly	XLK Poly
Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)	0	0

SecondaryRadiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)

Time frame:: Minimum 5 years, up to 7.6 years
Reported as:: Number · percentage of knees

Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)
percentage of knees	GVF Poly	XLK Poly
Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)	2.0	1.4

Adverse events

Collected over Intraoperatively and postoperatively through 6 years.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
GVF Poly	—	16/461 (3.5%)	146/461 (31.7%)
XLK Poly	—	15/477 (3.1%)	164/477 (34.4%)

Most frequent serious events

Showing 10 of 18

Most frequent serious events
Event	GVF Poly	XLK Poly
DeathGeneral disorders	5/461	4/477
LooseningProduct Issues	3/461	0/477
DeathInfections and infestations	2/461	0/477
DislocationProduct Issues	1/461	2/477
Other - Flexion InstabilityMusculoskeletal and connective tissue disorders	1/461	0/477
Other - Left Hip RevisionMusculoskeletal and connective tissue disorders	1/461	0/477
Other - Severe Low Back PainMusculoskeletal and connective tissue disorders	1/461	0/477
Other - Stage 4 Terminal CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/461	0/477
Other - Stage 4 CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/461	0/477
Other - Had fall and fractured left shoulder and had a concussionInjury, poisoning and procedural complications	0/461	1/477

Most frequent other events

Showing 10 of 72

Most frequent other events
Event	GVF Poly	XLK Poly
MusculoskeletalMusculoskeletal and connective tissue disorders	30/461	37/477
PainGeneral disorders	15/461	17/477
Stiffness, Arthrofibrosis, Ankylosis, Limited Range of MotionMusculoskeletal and connective tissue disorders	12/461	9/477
MusculoskeletalSurgical and medical procedures	10/461	10/477
CardiovascularCardiac disorders	7/461	8/477
Peri-op AE - OtherSurgical and medical procedures	4/461	8/477
Central Nervous SystemNervous system disorders	5/461	7/477
InfectionInfections and infestations	6/461	5/477
Thrombosis/ThrombophlebitisVascular disorders	6/461	0/477
MusculoskeletalInjury, poisoning and procedural complications	3/461	5/477

Baseline characteristics

Enrolled Subjects

Age, Continuous
Age, Continuous(years)	GVF Poly	XLK Poly	Total
Mean	66.3 ± 8.5	66.4 ± 8.5	66.3 ± 8.5

Sex: Female, Male
Sex: Female, Male(Participants)	GVF Poly	XLK Poly	Total
Female	290	308	598
Male	159	169	328

Region of Enrollment
Region of Enrollment(participants)	GVF Poly	XLK Poly	Total
United States	449	477	926

Study locations

9 sites

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

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2005 to primary completion in May 2013, 99 months.

Results were first posted in Jul 2016, 3 years 2 months after primary completion.

Of 142 industry-sponsored interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 33. This study's 99 months is above that.

Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 7, 2006
First posted: Feb 9, 2006
StartActual: Feb 1, 2005
Primary completionActual: May 1, 2013
CompletionActual: May 1, 2013
Results first posted: Jul 15, 2016
Last update: Apr 24, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00289133
Lead sponsor: DePuy Orthopaedics
Responsible party: Sponsor
First posted: Feb 9, 2006
Start date: Feb 1, 2005
Primary completion: May 1, 2013
Completion: May 1, 2013
Results posted: Jul 15, 2016
Last update: Apr 24, 2017

Study contacts

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

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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