Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation
Phase: NA
Conditions: Osteoarthritis
Sponsor: Zimmer Biomet

 
 
Vanguard Deep Dish 
Protocol number: BMETEU.CR.EU13B 
 
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Clinical Evaluation Of Vanguard 
Deep Dish Rotating Platform Knee 
 
Protocol number: BMETEU.CR.EU13B 
Protocol date:29-Apr-2016 
NCT number: NCT00753090 
 
 
 

 
 
Vanguard Deep Dish 
Protocol number: BMETEU.CR.EU13B 
 
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STUDY SYNOPSIS 
Complete Protocol Title 
Clinical Evaluation Of Vanguard Deep Dish Rotating 
Platform Knee  
Protocol Number 
BMETEU.CR.EU13B 
Short Protocol Title 
Vanguard Deep Dish 
Sponsor 
Biomet GSCC bv 
Hazeldonk 6530, 4836 LD Breda, The Netherlands 
Manufacturer 
Biomet Inc. 
Study Device(s) 
Vanguard DDRP 
Vanguard CR 
Study Objectives/Endpoints 
Primary Endpoint 
American Knee Society Knee Score at 2-year post-
operative. 
Secondary Endpoint 
- Patient success at 2 years postoperative 
- American Knee Society Score at each postoperative visit. 
- Radiographic evaluation at each postoperative visit. 
- Adverse events. 
- Survivorship at 10 year postoperative. 
Indications/Target Population 
Patients which are candidates for a total knee replacement 
because of gonarthrosis 
Inclusion/Exclusion Criteria 
Inclusion criteria 
1. Patients with a pre-operative knee score of < 70. 
2. Patients scheduled to undergo primary total knee 
replacement with any of the following indication: 
a. Painful and disabled knee joint resulting from 
osteoarthritis. 
b. One or more compartments are involved. 
3. Need to obtain pain relief and improve function. 
4. Ability and willingness to follow instructions, including 
control of weight and activity level, and to return for 
follow-up evaluations. 
5. A good nutritional state of the patient. 
6. Full skeletal maturity of the patient, patients who are 
at least 18 years of age. 
7. Patients of either sex. 
8. Consent form read, understood, and signed by patient. 
 
Exclusion criteria 
Absolute contraindications include the following 
diagnoses: 
a. Patients with a pre-operative knee score of >70. 
b. Infection. 

 
 
Vanguard Deep Dish 
Protocol number: BMETEU.CR.EU13B 
 
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c. Osteomyelitis. 
d. Previous partial or total prosthetic knee 
replacement on the operative side. 
e. Skeletal immaturity of the patient, patients who 
are less than 18 years of age. 
f. Sepsis. 
g. g. Patients who had body mass index >40. 
Study Design 
International, multicenter, randomised, controlled trial 
Clinical Phase 
Post-market 
Sample Size  
A total of 340 study subjects implanted with the study 
device per cohort. 
Length of Study 
13 years (3 years of enrollment (all sites) and 10 years of 
follow-up) 
Materials and Methods 
Case report forms were completed in hospital at Pre-op, 
Surgery, Immediate post-op, and the 6 week, 6 months, 1-
year, 2-year, 3-year, 5-year, 7-year, and 10-year intervals 
visits. 
Data Collection 
Paper 
Statistical Reporting 
Data collected was summarized and reported to each 
participating investigator. Statistical analysis was 
conducted by Zimmer Biomet. Survivorship was evaluated 
using Kaplan-Meier. 
Scores/Performance Assessments 
Knee Society Score, Oxford Knee Score, WOMAC, 
Forgotten Joint Score and Lower Extremity Activity Scale. 
Standards 
The PMCF is compliant with the below:  
• 
ISO 14155: 2020 - Clinical investigation of medical 
devices for human subjects - Good clinical practice.  
(*) The study protocol may have been drafted according 
to another version of the ISO 14155. Adverse Event 
definitions and reporting are according to ISO 
14155:2020.  
• 
The Declaration of Helsinki (DoH) - Ethical principles 
for medical research involving human subjects.  
Study Funding 
Funding for this clinical study is made available by Zimmer 
Biomet to support clinical data collection, IRB/EC review 
fees and other expenses associated with the conduct and 
execution of this study protocol as outlined in the fully 
executed Clinical Trial Agreement. 
 
 
 

 
 
Vanguard Deep Dish 
Protocol number: BMETEU.CR.EU13B 
 
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STATISTICAL ANALYSIS PLAN 
2.1 
Sample Size 
Patient populations for RCT group and NRCT group are determined based on non-inferiority 
test. Furthermore, non-inferiority is tested for both the primary endpoint and one of the 
secondary endpoints. Sample size calculation is conducted for each endpoint. The final 
patient number is the larger of the two sample sizes. 
 
Endpoint – American Knee Society Score (KSS) 
N=67 Correction for 15% Lost to Follow-up (approximately 7.5% each year): N=79 
Endpoint: Patient success rate at 2 year postoperative: 
N=127, Correction for 15% Lost to Follow-up (LTF) (approximately 7.5% each year): n=150 
The final patient population is the larger of these two sample sizes. Therefore, 150 cases are needed 
each arm. To compensate for possible lost to follow up add 20 more patients each arm, hence, the 
total number of cases for RCT group is 340. 
2.2 
Statistical Analysis 
2.2.1 Descriptive statistics 
Continuous outcome variables and their differences are analyzed with parametrical statistical 
techniques, such as t-tests, unless the normality assumption does not seem reasonable for the data, 
in which case non-parametric techniques are considered e.g. Wilcoxon/Mann-Whitney tests. 
Categorical outcome variables are analyzed with chi-square tests and/or Fisher's exact tests 
(depending on the expected values in the categories). For the relevant parameters (subsidence, 
survival pain and function) also the 95 percent confidence intervals are calculated. 
The effect of parameters such as age, sex and operators are evaluated using multiple variate analysis. 
All data are analyzed by blinded researchers. 
2.2.2 Interim analysis (if applicable) 
No interim analysis is performed, because it is expected that all patients are included in 6 months, so 
no patients will have obtained the primary outcome. 
The 2, 5 and 10 years results may if possible be published in orthopedic journals and at scientific 
meetings.