Trial Outcomes & Findings for Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study (NCT NCT00289133)

Last Updated: 2017-04-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

938 participants

Primary outcome timeframe

5 years

Results posted on

2017-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	GVF Poly Gamma Vacuum Foil polyethylene tibial component	XLK Poly Cross-linked polyethylene tibial component
Overall Study STARTED	461	477
Overall Study COMPLETED	189	179
Overall Study NOT COMPLETED	272	298

Reasons for withdrawal

Reasons for withdrawal
Measure	GVF Poly Gamma Vacuum Foil polyethylene tibial component	XLK Poly Cross-linked polyethylene tibial component
Overall Study Non-study device implanted	12	0
Overall Study Protocol Violation	32	38
Overall Study Withdrawal by Subject	9	10
Overall Study Death	5	10
Overall Study Lost to Follow-up - Hurricane Katri	73	74
Overall Study Physician Decision	41	45
Overall Study Revision	8	6
Overall Study Lost to Follow-up	92	115

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GVF Poly n=449 Participants Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=477 Participants Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert	Total n=926 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 8.5 • n=5 Participants	66.4 years STANDARD_DEVIATION 8.5 • n=7 Participants	66.3 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	290 Participants n=5 Participants	308 Participants n=7 Participants	598 Participants n=5 Participants
Sex: Female, Male Male	159 Participants n=5 Participants	169 Participants n=7 Participants	328 Participants n=5 Participants
Region of Enrollment United States	449 participants n=5 Participants	477 participants n=7 Participants	926 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Survivorship can only be calculated on knees (not participants as some study subjects had bilateral knees in the study) with post-operative follow-up. 35 knees were excluded due to post-operative follow-up not being available. 67 knees were excluded due to protocol violations.

Outcome measures

Outcome measures
Measure	GVF Poly n=402 number of knees Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=422 number of knees Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
Survivorship (Revision of Any Component for Any Reason)	96.8 percentage of knees Interval 93.9 to 98.4	98.1 percentage of knees Interval 95.6 to 99.2

SECONDARY outcome

Timeframe: 2 year

Population: The number of knees analyzed was the number available for analysis at this post-operative timepoint.

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.

Outcome measures

Outcome measures
Measure	GVF Poly n=240 Knees Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=239 Knees Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
American Knee Society Evaluation - Total Score	94.7 scores on a scale Standard Deviation 7.9	93.5 scores on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: Minimum 5 years, up to 7.6 years

Population: The number of knees analyzed was the number available for analysis at this post-operative timepoint.

Outcome measures

Outcome measures
Measure	GVF Poly n=145 Knees Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=146 Knees Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
American Knee Society Evaluation - Total Score	93.5 scores on a scale Standard Deviation 9.2	93.1 scores on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: 2 year

Population: The number of knees analyzed was the number available for analysis at this post-operative timepoint.

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.

Outcome measures

Outcome measures
Measure	GVF Poly n=225 Knees Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=221 Knees Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score	10.2 scores (points) on a scale Standard Deviation 13.4	11.5 scores (points) on a scale Standard Deviation 15.3

SECONDARY outcome

Timeframe: Minimum 5 years, up to 7.6 years

Population: The number of knees analyzed was the number available for analysis at this post-operative timepoint.

Outcome measures

Outcome measures
Measure	GVF Poly n=139 Knees Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=134 Knees Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score	11.0 scores (points) on a scale Standard Deviation 14.1	9.8 scores (points) on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: Minimum 5 years, up to 7.6 years

Population: The number of knees analyzed was the number available for analysis at this post-operative timepoint.

Outcome measures

Outcome measures
Measure	GVF Poly n=148 Knees Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=144 Knees Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)	9.5 percentage of knees	7.6 percentage of knees

SECONDARY outcome

Timeframe: Minimum 5 years, up to 7.6 years

Population: The number of knees in which the radiographs were analyzed was the number available for analysis at this post-operative timepoint.

Outcome measures

Outcome measures
Measure	GVF Poly n=148 Knees Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=144 Knees Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)	0 percentage of knees	2.1 percentage of knees

SECONDARY outcome

Timeframe: Minimum 5 years, up to 7.6 years

Population: The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.

Outcome measures

Outcome measures
Measure	GVF Poly n=148 Knees Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=144 Knees Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)	0 percentage of knees	0 percentage of knees

SECONDARY outcome

Timeframe: Minimum 5 years, up to 7.6 years

Population: The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.

Outcome measures

Outcome measures
Measure	GVF Poly n=148 Knees Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert	XLK Poly n=144 Knees Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)	2.0 percentage of knees	1.4 percentage of knees

Adverse Events

GVF Poly

Serious events: 16 serious events

Other events: 146 other events

Deaths: 0 deaths

XLK Poly

Serious events: 15 serious events

Other events: 164 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Portfolio Leader

DePuy Orthopaedics, Inc.

Phone: 574-372-7231

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	GVF Poly n=461 participants at risk Gamma Vacuum Foil polyethylene tibial component	XLK Poly n=477 participants at risk Cross-linked polyethylene tibial component
General disorders Death	1.1% 5/461 • Number of events 5 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.84% 4/477 • Number of events 4 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Infections and infestations Death	0.43% 2/461 • Number of events 2 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.00% 0/477 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Injury, poisoning and procedural complications Other - Had fall and fractured left shoulder and had a concussion	0.00% 0/461 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.21% 1/477 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Musculoskeletal and connective tissue disorders Other - Flexion Instability	0.22% 1/461 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.00% 0/477 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Musculoskeletal and connective tissue disorders Other - Left Hip Revision	0.22% 1/461 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.00% 0/477 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Musculoskeletal and connective tissue disorders Other - Severe Low Back Pain	0.22% 1/461 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.00% 0/477 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other - Death	0.00% 0/461 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.21% 1/477 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other - Ovarian Cancer	0.00% 0/461 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.21% 1/477 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other - Stage 4 Terminal Cancer	0.22% 1/461 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.00% 0/477 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other - Stage 4 Cancer	0.22% 1/461 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.00% 0/477 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Respiratory, thoracic and mediastinal disorders Other - Death	0.00% 0/461 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.21% 1/477 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Social circumstances Other - Death	0.00% 0/461 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.21% 1/477 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Surgical and medical procedures Other - Follow-up Left Knee Arthroscope	0.00% 0/461 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.21% 1/477 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other - Glioblastoma	0.00% 0/461 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.21% 1/477 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Surgical and medical procedures Other - Fall Injured Quad Repair	0.00% 0/461 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.21% 1/477 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Product Issues Dislocation	0.22% 1/461 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.42% 2/477 • Number of events 2 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Product Issues Loosening	0.65% 3/461 • Number of events 3 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.00% 0/477 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Nervous system disorders Central Nervous System	0.00% 0/461 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.	0.21% 1/477 • Number of events 1 • Intraoperatively and postoperatively through 6 years. Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.