A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee
Phase: NA
Conditions: Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Sponsor: Zimmer Biomet

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
1 
 
A PROSPECTIVE CONTROLLED MULTI-CENTER STUDY ON 
VANGUARD™ COMPLETE KNEE & VANGUARD™ HIGH FLEX RP KNEE 
 
 
GENERAL INFORMATION 
 
Principal Investigators 
 
Yong In, M.D., Ph.D. – 75 Cases 
Chul-Won Ha, M.D., Ph.D. – 75 Cases 
Myung Chul Lee, M.D., Ph.D. – 75 Cases 
Seong-II Bin, M.D., Ph.D. – 75 Cases 
 
Principal investigators are responsible for the overall project and performing the surgical 
procedures in all study groups. Responsible for applying for ethical and management 
approval, recruitment of patients, obtaining patient consent, managing postoperative 
care of patients and adverse event reporting. 
 
Study Sponsor 
 
Biomet Korea 
 
Study sponsors take responsibility for initiation, management, and/or financing of a 
clinical studies at investigational sites. 
 
Study Monitor in Korea 
 
Anna Lee 
 
Study monitors are responsible for carrying out the monitoring procedure as indicated in 
the protocol. 
 
 
 
STUDY OBJECTIVE 
 
The primary objectives of this clinical study include: 
 
• 
Evaluate size fit and long term performance of Vanguard Complete Knee 
(“Fixed”) System in Asian and Latino population Compare Vanguard High Flex 
Rotating Platform (“High Flex”) Knee System to Vanguard Complete Knee 
System in Asian population in terms of: 
o Early ROM 
o Clinical outcomes 
 
• 
Compare current design to new design of Vanguard High Flex Rotating 
Platform  Knee System in terms of : 
o Early ROM 
o Clinical outcomes  
 
DEVICE DESCRIPTION 
 
Vanguard Complete Knee 

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
2 
 
 
Vanguard Knee is a metal and polyethylene system designed to replace the body’s 
natural knee joint and is indicated for cemented tibial and cementless femoral use.  
The system contains three (3) primary components and one (1) peripheral 
component.  The primary components include, femoral, tibial, and bearing 
components, while the peripheral component is the patella button.  The use of the 
patella button is optional.  
  
 
 
Vanguard High Flex Rotating Platform Knee (current design) 
 
Vanguard High Flex RP knee is an extension to the existing Vanguard Knee and has 
been specifically designed to facilitate greater than 135 degrees of knee flexion as 
required by certain patients. Specifically the Vanguard High-Flex Knee components 
are required to be able to flex to 150° without point loading or falling off the back of 
the tibia and to be hyper extended to 15°. It should be noted that this range of motion 
would only be obtained where the patient had similar flexion and hyperextension 
ability prior to the arthroplasty. The decision on which rotating platform variant to use 
is at the discretion of the operating surgeon 
 
Mobile bearing knees are considered advantages as they enable improved 
congruency between the femoral component and the bearing, compared with a fixed 
bearing, which results in lower contact stresses of the bearing, thereby reducing wear. 
Another advantage of mobile bearings is the ability for self-alignment, which reduces 
wear caused by mal-lalignment, enabling the knee to function more naturally and 
prevents torsion stress on the implant/bone cement/bone interface which may cause 
loosening.  
 
The tibial tray of the High Flex knee is available in 9 sizes, from 59 to 91mm in 4 mm 
increments, in interkok finish for cemented applications or with porous plasma 
sprayed titanium coating for cementless use. It is manufactured from cast cobalt 
chromium alloy. The stem has a tapered cone geometry for press fit stability. In the 
cementless option the proximal 1/3 of the stem is porous coated with plasma sprayed 
titanium. (Note: The tibial trays are manufactured and CE marked by Biomet Spain).  
 
The femoral component is offered in thirteen sizes from 55 to 80mm in 2.5 mm 
increment, it is anatomic in design (i.e. right and left). It is manufactured from cast 
cobalt chromium alloy.  
 
The bearing is compression moulded UHMPWE (ArCom). It is matched to the 
femoral component and is available in 5 thickness from 10-18mm (2mm increments) 
and 13 sizes from 50mm to 80mm (2.5mm increments). The bearing was designed 
specifically for the High-Flex to allow rotation of ±8° without overhang.  
 
The patella has an anatomic design and is matched to the thirteen sizes of femoral 
component patella tracks. It is available in of one thickness only. It is compression 
moulded from UHMWPE (ArCom). Use of the patella button is optional at the 
discretion of the surgeon.  
 
 
 
 
 

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
3 
 
STUDY DESIGN 
 
The study is designed as a prospective, controlled multi-center study including 
sites from Korea, Japan and Mexico.  
 
To achieve all the primary objectives, the study will include 2 subgroups. The relationship 
between the two subgroups is illustrated in the following table and graph: 
 
Subgroup  Objectives 
Trial 
Group 
Control Group 
Design 
Endpoint(s) 
2 
Compare early 
ROM, Clinical 
Outcomes, 
assess Kinetic 
and Kinematic 
characteristics 
between 
Vanguard 
Complete Knee 
System and 
Vanguard High 
Flex Rotating 
Platform Knee 
System*  
 
Vanguard 
Complete 
Knee 
System w/ 
std tray  
(part of 
subgroup 
1 control) 
Vanguard 
High Flex RP 
(Current 
Design) 
RCT  
ROM, AKS,. 
4** 
Compare early 
ROM, clinical 
outcomes and 
assess Kinetic 
and Kinematic 
characteristics 
between current 
design and new 
design of 
Vanguard High 
Flex Rotating 
Platform Knee 
Systems 
 
Vanguard 
High Flex 
RP (New 
Design) 
Vanguard High 
Flex RP (same 
as control from 
subgroup 2) 
Historical/concurrent 
control 
ROM,  AKS, 
Survivorship 
and 
Fluoroscopic 
analysis, Gait 
lab analysis, 
patella clunk 
and crepitus. 
*Japanese sites will include equal number of Healthy Knees for ROM, Kinetic and Kinematic analysis. 
** Subgroup 4 will be initiated once the new design of Vanguard high flex RP is release. 
 
 

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INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
5 
 
• 
Ability and willingness of the patient to follow instructions, including control of 
weight and activity level 
• 
A good nutritional state of the patient, and  
• 
The patient must have reached full skeletal maturity 
 
Exclusion Criteria 
 
In accordance with Absolute and Relative Contraindications for use for Vanguard 
Complete Knee System and Vanguard High Flex Rotating Platform Knee System. 
 
Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a 
previous joint replacement. 
 
Relative contraindications include:  
A. Uncooperative patient or patient with neurologic disorders who are incapable of 
following directions,  
B. Osteoporosis,  
C. Metabolic disorders which may impair bone formation,  
D. Osteomalacia,  
E. Distant foci of infections which may spread to the implant site,  
F. Rapid joint destruction, marked bone loss or bone resorption apparent on 
roentgenogram,  
G. Vascular insufficiency, muscular atrophy, neuromuscular disease,  
H. Incomplete or deficient soft tissue surrounding the knee. 
 
ENDPOINTS 
 
 
SUBGROUP 2 
SUBGROUP 4 
PRIMARY 
ENDPOINTS* 
Range of Motion at 
1 yr postop. 
AKS 
at 
1 
year 
postop 
Range of Motion at 
1 yr postop. 
AKS at 1 year post 
op 
SECONDARY 
ENDPOINTS 
At 
all 
follow-up 
visits: 
Survivorship 
American 
Knee 
Society Score. 
Range of Motion   
Radiographic 
Assessment 
Patient Satisfaction 
– EQ5D 
Complications 
including revisions 
Patella Clunk and 
Crepitus 
 
At 
all 
follow-up 
visits: 
Survivorship 
American 
Knee 
Society Score. 
Range of Motion 
Radiographic 
Assessment  
Patient Satisfaction 
– EQ5D 
- OKS 
- FJS 
Complications 
including revisions 
Patella Clunk and 
Crepitus 
 
*For sample size calculations. 
 

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
6 
 
 
PARTICIPANT POPULATION (SAMPLE SIZE) 
 
Participant population is determined based on primary/secondary endpoints of each 
subgroup following superiority or non-inferiority methodologies. Minimum sample 
sizes are determined in order to prove the hypotheses. 
 
 
 
Subgroup 2  - Primary Endpoint  Range of Motion at 1 year postoperative 
Superiority test 
 
Null Hypothesis:  
 
H0  
μt = μc 
 
Alternative Hypothesis: Ha  
μt = μc + d 
 
 
μt: mean of ROM in the trial group (Vanguard Complete Knee) at 1year postoperative. 
   
μc: mean of ROM in the control group (VG RP Knee) at 1 year postoperative. 
 
a = 0.025  
 
Significance Level (95% confidence) 
 
β = 0.20  
80% Power 
 
 
d = 5 (degrees) 
Clinically Relevant Difference in ROM based on literature and 
engineering input. 
 
ξ = 17.5 
 
Estimate 
standard 
deviation 
of 
ROM 
at 
1 
year 
postoperative. This value is based on results (preop and 1 year 
postop) from literature1 
 
N = 231 
Consider lost to follow-up at 1 year postop, therefore the adjusted sample size is set 
as 250 knees per group (a total of 500 knees). 
 
Subgroup 2  - Secondary Endpoint AKS at 1 year postoperative 
Non-inferiority test 
 
Null Hypothesis:  
 
H0  
μt = μc 
 
Alternative Hypothesis: Ha  
μt = μc + d 
 
 
μt: mean of AKS score in the trial group (Vanguard Complete Knee) at 1 year 
postoperative. 
   
μc: mean of AKS score the control group (VG RP Knee) at 1 year postoperative. 
                                           
1 Miner AL, Lingard EA, Wright EA, Sledge CB, Katz JN; Knee range of motion after total knee 
arthroplasty: how important is this as an outcome measure, J Arthroplasty. 2003 Apr;18(3):286-94.  
 

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
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a = 0.025 
 
Significance Level (95% confidence) 
 
β = 0.10  
80% Power 
 
Z1-a/2 = 1.96 
Z1- β = 1.28 
 
d = 10 points 
Clinically Relevant Difference in Pain. 
 
ξ = 15 
 
Estimate standard deviation of AKS at 1 year postoperative. 
This value has been based on results from Biomet studies 
 
N = 48 
Consider possible lost to follow-up at 1 year postop, therefore the adjusted sample 
size is set as 51 knees per group. The final sample size for subgroup 2 is larger of 
the two sample sizes: 250 knees per group. 
 
 
Therefore there will be 250 Vanguard Complete Knee will be compared to 250 
Vanguard High Flex RP knee for subgroup 2 study.   
Due to unknown release schedule for new designed VG High Flex RP Knee, sample 
size of subgroup 4 will be determined at time of the product release. Nevertheless the 
sample size will be determined based on the comparison to results of 250 VG High 
Flex RP knee of current design from subgroup 2.  
 
 
 
RANDOMIZATION 
 
For subgroup 2 study, patients will be randomized to receive Vanguard Complete 
Knee (trial group), or Vanguard High Flex RP Knee (control group). Patients have an 
equal opportunity of being assigned to the trial group or control group. The 
randomization will occur via a random number generator (manual or computer). The 
doctor or other health care professional does not choose the participants for each 
group. For Patients satisfying inclusion criteria, randomization will occur by retrieving 
the next randomly generated group assignment.  
 
INSTITUTIONS 
 
There will be a maximum of 8 sites from Korea and Japan in subgroup 2. The 
number of sites for subgroup 4 will be determined once new design of Vanguard High 
Flex RP is released. 
 
PARTICIPANT DATA MANAGEMENT 
 
The following table summarizes data collection required during the course of the 
study. 
 
SUBGROUP 2 
PRE-
OP 
SURGERY IMMEDIATE 
POST-OP 
3 
MO 
6 
MO 
1 
YR 
3 
YR 
5 
YR 
7 
YR 
10  
YR 
Informed 
Consent 
X 
 
 
 
 
 
 
 
 
 
Demographic 
X 
 
 
 
 
 
 
 
 
 

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
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and Historical 
Record 
Preoperative 
AKS 
X 
 
 
 
 
 
 
 
 
 
Operative 
Record 
 
X 
 
 
 
 
 
 
 
 
Immediate 
Post-Operative 
Radiographic 
Assessment 
(Bench Mark) 
 
 
X 
 
 
 
 
 
 
 
Postoperative 
AKS (Including 
ROM) 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Patella Clunk 
and Crepitus 
 
 
 
X 
X 
X 
 
 
 
 
EQ5D 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Radiographic 
Assessment 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Complications 
& Revisions 
 
 
 
Anytime 
 
 
 
 
SUBGROUP 4 
PRE-
OP 
SURGERY IMMEDIATE 
POST-OP 
3 
MO 
6 
MO 
1 
YR 
3 
YR 
5 
YR 
7 
YR 
10  
YR 
Informed 
Consent 
X 
 
 
 
 
 
 
 
 
 
Demographic 
and Historical 
Record 
X 
 
 
 
 
 
 
 
 
 
Preoperative 
AKS 
X 
 
 
 
 
 
 
 
 
 
Operative 
Record 
 
X 
 
 
 
 
 
 
 
 
Immediate Post-
Operative 
Radiographic 
Assessment 
(Bench Mark) 
 
 
X 
 
 
 
 
 
 
 
Postoperative 
AKS (Including 
ROM) 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Patella Clunk 
and Crepitus 
 
 
 
X 
X 
X 
X 
X 
X 
X 
EQ5D/SF36 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Radiographic 
Assessment 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Complications & 
Revisions 
 
 
 
Anytime 
 
 
 

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
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PARTICIPANT EVALUATION SCHEDULES 
 
All study Participants are expected to return for clinical, kinetic and kinematic 
analysis if any and radiographic evaluation at specific follow-up intervals.  The 
following table summarizes the schedule for post-operative follow-up time intervals: 
 
 
Evaluation Schedule 
Interval 
Follow-Up 
Window 
Months 
Post-Op Range 
Immediate Post-
Op 
± 2 weeks 
Immediate post-
op 
< 2 weeks 
3 month follow-up 
± 1 month 
2-4 
6 month follow-up 
± 1 month 
5-7 
1 year follow-up 
± 2 months 
10-14 
3 year follow-up 
± 3 months 
33-39 
5 year follow-up 
± 3 months 
57-63 
7 year follow-up 
± 3 months 
81-87 
10 year follow-up 
± 3 months 
117 - 123 
 
COMPLICATIONS (ADVERSE EVENTS) 
 
All adverse events, device related (see Risk Analysis Section) or non-device related, 
are to be recorded.  Anticipated adverse events are defined, but not limited to, the 
following: 
• 
Operative side knee manipulations or injections 
• 
Operative side dislocations 
• 
Operative side aspiration of joint fluids 
• 
Falls 
• 
Accidents- motor vehicle, motorcycle, ATV, etc. 
• 
Death 
• 
Any event in which the subject requires hospitalization or outpatient  
medical attention, including but not limited to: myocardial infarction, 
cerebral vascular accident, pulmonary emboli, gastrointestinal disorders, 
or a new diagnosis of a chronic condition (lung disease, renal disease, 
cancer, diabetes mellitus, hematological abnormalities, etc.). 
 
RADIOGRAPHIC PROTOCOL 
 
1. Radiographic Views  
The study requires a standard anteroposterior view, mediolateral view, 
and a skyline patellar view. 
 
2. Reviewer 
The study investigator will assess his own patient’s radiographs.   

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
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3. Assessment Procedure 
• 
Assessments will be recorded on the following two radiographic 
assessment reports:  
o Form XR100 (immediate post-operative) 
o Form XR200 (6 week, 6 month, 1 year, 3 year, 5 year, 
7year and 10 year. 
• 
The radiographic films will be marked for measurements as 
described in the following “Measurement angles and reference 
points” section of this document.  These “marked” radiographs 
will be used to determine the implant femoral flexion angle (α), 
tibial angle (β), total valgus angle (Ω), tibial angle (σ), and femoral 
flexion (γ). 
• 
The immediate post-operative film will be used as an index for 
subsequent follow-up assessments.   
 
The radiographic assessment definitions are as follows: 
• 
Anteroposterior Radiograph:  
This radiographic view can be obtained with the participant in the 
standing or recumbent position. 
• 
Mediolateral Radiograph:  
This radiographic view can be obtained with the participant in the 
standing or recumbent position. 
• 
Skyline Radiograph: 
This radiograph view can be obtained with the patello-femoral joint 
in flexion 
• 
Radiolucency or Radiolucent Lines: 
A radiographic clearing or line not exceeding 2mm in width at the 
bone/cement or cement/implant interface 
• 
Osteolysis:  
A progressive radiolucency > 2mm in two or more zones not present 
on immediate postoperative radiographs and/or a bony destructive 
lesion that is progressive in nature. 
• 
Migration/Subsidence: 
A component migration of > 3 mm or > 3° as compared to immediate 
post-operative radiographs is considered a failure. 
 
DATA COLLECTION 
All sites will be required to complete and submit case report forms on Biomet’s online 
database, Joint Assist 2.0, in a timely manner.  Forms will be monitored for completeness 
and accuracy.  
 
Further, it is imperative that the investigator answers all questions on the case report forms.  
All data should be accurate, indelible, legible, dated on the date of entry, and signed by 
initials, and/or formal signature by the authorized personnel documenting the data.  
 
MONITORING PLAN 
 
Prior to commencing the study the Monitor will provide the investigators with the necessary 
information to enable him/her to carry out his responsibilities. This information includes but 
not limited to: 
 
• 
Investigator Brochure i.e. study protocol, investigator responsibilities, device 
information, etc. 

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
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• 
Ethical Committee Approval Information. 
 
• 
Case Report Forms. 
 
• 
Patient Consent Forms 
 
• 
EDC  user manual 
 
The monitor of the evaluation periodically reviews the post-operative follow-up dates on all 
subjects for each evaluator.  A follow-up schedule is then sent to each investigator, which 
illustrates any follow-up, reports which are due or missing.  Every effort is made to assure 
that follow-up reports are completed in a timely manner, including contacting the evaluator 
by post, telephone or by personal visit when necessary.  Also, during the course of the 
evaluation, the monitor will conduct periodic discussions with the investigator or staff to 
ensure that the evaluation is being conducted in accordance with the protocol.  The monitor 
will maintain records of each visit or discussion.   
 
CONFIDENTIALITY 
To ensure study patients’ privacy, all patients will be identified by unique identification 
numbers. All case report forms will only include patient IDs. It is the responsibility of the 
investigator to maintain a list of patient identification and Joint Assist 2.0 ID numbers. 
 
Further the Joint Assist database is restricted, allowing a doctor to only view and enter data 
from his own patients.  User authentication is required to view research data.  The data is 
transmitted to a centralized database through a secured (SSL) channel on the Internet.  
Data in transit is in 128-bit encryption.  The access to the centralized database is limited to 
those who are responsible for maintaining the database. 
 
RISK ANALYSIS 
 
This clinical study is to collect data on the Vanguard DD RP Knee, which is intended 
to help the participant gain mobility and decrease pain.  Risks associated with this 
knee system include general surgical and knee arthroplasty risks. Due to the 
investigational nature of the system, there are unknown risks. 
 
General Surgical Risks 
 
As with any surgical procedure, there are risks involved with total joint replacement 
surgery.  Potential adverse events include, but are not limited to: early or late 
infection perhaps necessitating device removal; component dislocation; damage to 
nerves and blood vessels; fracture of the bone or device; device loosening; allergic 
reactions to the metallic devices; phlebitis; long-term swelling; pulmonary 
embolization; and delayed wound healing. Other potential adverse effects include: 
prolonged illness; hematoma; wound dehiscence and/or drainage; the need for blood 
transfusions and/or further surgery; or permanent pain; deformity; and inconvenience. 
Risks associated with the anesthetic are those such as permanent brain damage, 
pneumonia, blood clots, and heart attack. Rarely some adverse events may be fatal.  
These possible adverse events are not unique to the Vanguard™ RP System and, as 
stated above, may occur with any total joint replacement surgery. 
 
As with any joint replacement post-operative activity, limitations may be imposed 

INT.CR.RROW1 
 
Vanguard High Flex RP V2.1 
 
05th-Nov-2014 
 
12 
 
depending upon the participant’s age, general health, baseline (pre-operative) activity 
level and baseline (pre-operative) condition of the knee and other joints. 
 
 
Potential Risks Associated with Vanguard™ RP Knee System 
 
The safety and efficacy of the Vanguard™ RP Knee System has not been thoroughly 
demonstrated clinically, participants participating in the study may be subject to 
increased risks and/or adverse events including, but not limited to: 
1. Material sensitivity reactions 
2. Early or late post-operative infection and/or allergic reaction 
3. Intra-operative bone perforation or fracture 
4. Loosening or migration of implants 
5. Periarticular calcification or ossification, with or without impediment of joint 
mobility 
6. Inadequate range of motion 
7. Dislocation or subluxation of device 
8. Fatigue fracture of components 
9. Fretting or corrosion of implant interfaces 
10. Wear and/or deformation of articulating surfaces 
11. Valgus/Varus deformity 
12. Transient peroneal palsy secondary to surgical manipulation and increased 
joint movement 
13. Patellar tendon rupture and ligamentous laxity 
14. Intra-operative or post operative bone fracture 
15. Post operative pain and/or delayed wound healing 
16. Inadequate lubrication 
17. Implant of the device may require a more demanding implantation procedure 
with greater surgical exposure and prolonged surgical time 
18. Damage to surrounding tissues, cartilage, or tendons 
19. Long term swelling 
20. Excessive bleeding 
21. Instability 
 
 
Minimization of Risk 
 
With the increased understanding of failure modes for mobile bearing knees, pre-
clinical testing and clinical results found in the literature, it is believed that none of 
the previously mentioned adverse events will occur in significant numbers.  This 
investigational plan has reduced the potential risk to the participant through the 
following methods: 
 
1. By defining a participant population that limits the exposure of the 
device to participants conforming to the proposed indications, 
exclusions, and age requirements 
2. The surgical technique has been developed to help eliminate potential 
operative difficulties. 
 
 
 
 
 
 

INT.CR.RROW1 
 
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REFERENCES 
 
1. Mulholland, S.J. and U.P. Wyss, Activities of daily living in non-Western cultures: 
range of motion requirements for hip and knee joint implants. Int J Rehabil Res, 2001. 
24(3): p. 191-8. 
2. Thambyah, A., J.C. Goh, and S.D. De, Contact stresses in the knee joint in deep 
flexion. Med Eng Phys, 2005. 27(4): p. 329-35. 
3. Masashi Tamaki, Tetsuya Tomita, Takaharu Yamazaki, William J. Hozack, Hideki 
Yoshikawa,  and Kazuomi Sugamoto,  In Vivo Kinematic Analysis of a High-Flexion 
Posterior Stabilized Fixed-Bearing Knee Prosthesis in Deep Knee-Bending Motion; 
The Journal of Arthroplasty Vol. 23 No. 6 2008 
4. Kouichi Kanekasu, Scott A. Banks, Shigeru Honjo, Osanari Nakata, and Hiromi Kato; 
Fluoroscopic Analysis of Knee Arthroplasty Kinematics During Deep Flexion Kneeling; 
The Journal of Arthroplasty Vol. 19 No. 8 2004 
Alberto A. Bolanos, Wayne A. Colizza, Peter D. McCann, Robert S. Gotlin, Mary E. Wootten,  
Barbara A. Kahn, and John N. Insall, A Comparison of Isokinetic Strength Testing and Gait 
Analysis in Patients With Posterior Cruciate-Retaining and Substituting Knee Arthroplasties; 
The Journal of Arthroplasty Vol. 13 No. 8 1998