Trial Outcomes & Findings for Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System (NCT NCT02175576)

NCT ID: NCT02175576

Last Updated: 2023-02-21

Results Overview

Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2023-02-21

Participant Flow

After obtaining informed consent, participants were evaluated according to protocol-defined eligibility (inclusion and exclusion) criteria. If a participant did not meet the eligibility criteria, he or she was excluded from participation and not assigned to a study group.

Unit of analysis: Knees

Participant milestones

Measure	Vanguard XP Bicruciate Knee System Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.	Vanguard CR Knee System Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Overall Study STARTED	20 22	30 33
Overall Study 12 Month Follow-Up Visit	8 10	18 21
Overall Study COMPLETED	0 0	0 0
Overall Study NOT COMPLETED	20 22	30 33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Vanguard XP Bicruciate Knee System n=22 Knees Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.	Vanguard CR Knee System n=33 Knees Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.	Total n=55 Knees Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 8.0 • n=22 Knees	66.4 years STANDARD_DEVIATION 7.3 • n=33 Knees	65.5 years STANDARD_DEVIATION 7.6 • n=55 Knees
Sex: Female, Male Female	13 Knees n=22 Knees	17 Knees n=33 Knees	30 Knees n=55 Knees
Sex: Female, Male Male	9 Knees n=22 Knees	16 Knees n=33 Knees	25 Knees n=55 Knees
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 Participants n=20 Participants	30 Participants n=30 Participants	50 Participants n=50 Participants
Modified Knee Society Score	111.0 score on a scale STANDARD_DEVIATION 27.0 • n=22 Knees	114.5 score on a scale STANDARD_DEVIATION 27.6 • n=33 Knees	113.1 score on a scale STANDARD_DEVIATION 27.4 • n=55 Knees

PRIMARY outcome

Timeframe: 12 Months

Population: All knees that contributed a SANE score for function at 12 months were included in the analysis.

Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.

Outcome measures

Measure	Vanguard XP Bicruciate Knee System n=14 Knees Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.	Vanguard CR Knee System n=23 Knees Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)	1 Knees	2 Knees

SECONDARY outcome

Timeframe: 12 months

Population: All patients that contributed a Modified Knee Society Score (mKSS) at 12 months were included in the analysis.

The American Knee Society Score is part clinical exam and part patient administered assessment of the knee. The objective part of the score was collected in the clinic by qualified personnel. The functional and pain components of the score were collected by patient completed questionnaire. Total scores can range from 0 to 200, with higher scores indicating better outcomes.

Outcome measures

Measure	Vanguard XP Bicruciate Knee System n=10 Knees Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.	Vanguard CR Knee System n=21 Knees Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Modified Knee Society Score	164.6 score on a scale Standard Deviation 29.4	168.7 score on a scale Standard Deviation 30.9

SECONDARY outcome

Timeframe: 3 years

Population: Participants who were randomized, underwent surgery, and received the study device.

Number of study device revisions or removals reported during the study.

Outcome measures

Measure	Vanguard XP Bicruciate Knee System n=20 Participants Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.	Vanguard CR Knee System n=30 Participants Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Revisions/Removals	0 Revisions/Reoperations	0 Revisions/Reoperations

SECONDARY outcome

Timeframe: 12 Months

Population: All knees that contributed a SANE score for function at 12 months were included in the analysis.

Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.

Outcome measures

Measure	Vanguard XP Bicruciate Knee System n=14 Knees Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.	Vanguard CR Knee System n=23 Knees Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)	10 Knees	20 Knees

SECONDARY outcome

Timeframe: 12 Months

Population: All patients that contributed a patient satisfaction score at 12 months were included in the analysis.

Participants answered a survey which asked how they they would describe their satisfaction with their new joint. Options for answers included "I have never been happy," "Ok - but not perfect," "Happy," and "Very Happy."

Outcome measures

Measure	Vanguard XP Bicruciate Knee System n=14 Knees Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.	Vanguard CR Knee System n=23 Knees Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"	12 Knees	18 Knees

Adverse Events

Vanguard XP Bicruciate Knee System

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Vanguard CR Knee System

Serious events: 7 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vanguard XP Bicruciate Knee System n=1 participants at risk；n=20 participants at risk Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.	Vanguard CR Knee System n=3 participants at risk；n=30 participants at risk Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Musculoskeletal and connective tissue disorders Fracture of patella	0.00% 0/20 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	6.7% 2/30 • Number of events 2 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Musculoskeletal and connective tissue disorders Effusion	5.0% 1/20 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	10.0% 3/30 • Number of events 4 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Musculoskeletal and connective tissue disorders Instability Medial/Lateral	0.00% 0/20 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	3.3% 1/30 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Musculoskeletal and connective tissue disorders Stiff knee resulting in manipulation	5.0% 1/20 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	3.3% 1/30 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Musculoskeletal and connective tissue disorders Effusion/swelling and pain	10.0% 2/20 • Number of events 2 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	0.00% 0/30 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Musculoskeletal and connective tissue disorders Synvectomy and lysis of adhesions	5.0% 1/20 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	0.00% 0/30 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Nervous system disorders Sciatic nerve pain	5.0% 1/20 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	0.00% 0/30 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Musculoskeletal and connective tissue disorders Pain, stiffness, decrease in satisfaction	0.00% 0/20 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	3.3% 1/30 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.

Other adverse events

Measure	Vanguard XP Bicruciate Knee System n=1 participants at risk；n=20 participants at risk Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.	Vanguard CR Knee System n=3 participants at risk；n=30 participants at risk Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Musculoskeletal and connective tissue disorders Radiograph radiolucency seen under tibial platform	0.00% 0/1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	33.3% 1/3 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Nervous system disorders Nerve Deficit	0.00% 0/1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	33.3% 1/3 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Musculoskeletal and connective tissue disorders Periosteal reaction medial cortex	0.00% 0/1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	33.3% 1/3 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.
Musculoskeletal and connective tissue disorders Effusion and pain to knee	100.0% 1/1 • Number of events 1 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.	0.00% 0/3 • 3 years Per the study protocol, only device-related and serious adverse events were collected in this study.

Additional Information

Hillary Overholser

Zimmer Biomet

Phone: 574-933-4180

Email: hillary.overholser@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place