A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty
Phase: NA
Conditions: Degenerative Joint Disease, Avascular Necrosis
Sponsor: Zimmer Biomet

Rev.2 
 
 
 
 
 
 
 
 
 
 
 
 
 
A PROSPECTIVE CONTROLLED MULTI-CENTER STUDY ON  
 
M2A MAGNUM TOTAL HIP ARTHROPLASTY 
 
 
 
 
SPONSOR: Zimmer Biomet 
 
 
 
 
 
 
 
 
 
 
 
Protocol#: INT.CR.RROW2 
Revision 2 (July 21, 2015) 
 
 
 
 
 

Rev.2 
GENERAL INFORMATION 
 
Research Team 
 
 
Principal Investigators (Japan) 
Dr. Kenji Ohzono 
 
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 Sponsors 
 
Biomet Japan 
 
Study sponsors take responsibility for initiation, management, and/or financing of a 
clinical studies at investigational sites 
 
Study Monitor in Japan 
Takahito Nakai 
 
Study monitors are responsible for carrying out the monitoring procedure as indicated 
in the protocol. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Rev.2 
STUDY OBJECTIVE 
 
The primary objectives of this clinical study include: 
• 
Evaluate clinical efficacy and performance of M2A Magnum in Asian population 
in comparison to competitors’ similar products. 
• 
Investigate potential advantages of M2A Magnum compared to M2A Taper 
(28mm and 32mm) in terms of Range of Motion, Dislocation while maintaining 
the same function improvement and pain reduction. 
• 
Investigate Metal-ion release and renal function in M2A Total Hip Arthroplasty. 
 
DEVICE DESCRIPTION 
 
M2A Magnum 
 
The M2a-Magnum™ Large Metal Articulation is an ultra-high performance metal-on-metal 
articulation offering superior joint mechanic restoration and full compatibility with Biomet's 
clinically proven hip stems. Unlike ceramic-on-ceramic or traditional metal-on-polyethylene 
bearings, the M2a-Magnum™ system offers the stability and ROM of a big ball (≥38mm) in 
acetabulums as small as 44mm.  
• 
Allows for significant wear reduction compared with metal or ceramic-on polyethylene 
and the potential for higher stability and range of motion (ROM)  
• 
Features PPS® Porous Plasma Spray surface coating and full hemisphere geometry 
with four sets of paired fins  
• 
Six neck length offsets from -6 to +9mm  
• 
Available in shell sizes from 44-66mm (2mm increments) and head sizes 38-60mm 
(2mm increments)  
 
M2A Taper (28mm or 32 mm)  
 
The M2a-Taper Acetabular System consists of a titanium outer shell with cobalt 
chromium (Co-Cr-Mo) metallic liner, which articulates with a cobalt chromium (Co-Cr-
Mo) modular femoral head. The system is all metal – there is no polyethylene in the 
design.  
The outer surface of the acetabular shell is covered with a porous coating of 
Titanium (Ti-6Al-4V) per ASTM-F136 which ensures immediate component fixation 
and maximum bone-to-implant contact. The plasma sprayed surface consists of 
particles which are bonded together to form a random pattern of interconnecting 
pores. The Co-Cr-Mo liner fits into the Ti outer shell by means of a taper. The 
locking mechanism consists of a three-degree taper with a maximum engagement 
of 0.075 inches. The shell has inner diameters of either 28mm or 32mm. The 
28mm inner diameter is available in shell sizes 48mm through 70mm. The 32mm is 
available in shell sizes 52mm through 70mm. 
 
Bi-Metric XR and Taperloc can be used with M2A Taper and M2A Magnum in the 
study.  
 
 
STUDY DESIGN 
 
The study is designed as a prospective, controlled multi-center study..  
 
 
 

Rev.2 
Hypotheses: 
 
Study Hypotheses are established based on the primary objectives. Specifically: 
 
Hypothesis 1 – M2A Magnum will achieve the range of survivorships of 
competitors’ products at 2 year postop (based on the only available information on 
competitors’ products). 
 
Hypothesis 2 – M2A Magnum will have better Range of Motion compared to M2A 
Taper (28mm or 32mm) at 1 year postop 
 
Hypothesis 3 – M2A Magnum will have lower dislocation rate than M2A Taper 
(28mm or 32mm) at 5 year postop 
 
Accordingly the study will include 2 subgroup studies. The relationship between the 
2 subgroups is illustrated in the following table and graph: 
 
Subgroup  Objectives 
Trial Group 
Control Group 
Design 
Endpoint(s) 
1 
Evaluate long 
term 
performance and 
size fit of M2A 
Magnum in Asian 
population and in 
comparison with 
competitors’ 
similar products. 
 
M2A 
Magnum .  
Published data 
on Competitors’ 
similar product – 
ASR. 
Single arm cohort 
with Objective 
Performance 
Criteria 
(published data) 
Survivorship, 
HHS, UCLA, 
Patient 
Satisfaction, 
cup seating, 
neck angle at 
immediate 
postop (part 
of 
radiographic 
assessment). 
2 
Compare early 
ROM, Clinical 
Outcomes, 
Metal-ion release 
and dislocation  
between M2A 
Magnum and 
M2A Taper w/ 
conventional 
head sizes 
M2A 
Magnum 
M2A Taper  
RCT  
HHS, ROM, 
UCLA, 
Dislocation 
and Metal-ion 
release, renal 
function, MRI  
Assessment[, 
survivorship 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The study will be conducted over a period of 12 to 15 years. Patients from  
subgroups 1 and 2 will be followed at immediate postop, 3 months, 6 months, 1 
year, 2 years, 3 years, 4 years, 5 years, 7 years and 10 years.  
Subgroup 1  
Subgroup 2  
 

Rev.2 
 
PATIENT SELECTION 
 
All subjects, regardless of sex, race, or geographic location, must fit into the scope 
of the Inclusion / Exclusion criteria to be eligible for the study. If required per 
applicable regulations, all participants must sign an Informed Consent to be 
enrolled into the study. 
 
Inclusion Criteria 
 
 
Patients suitable for primary Total Hip Replacement 
Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the 
composite diagnoses of: 
a. Osteoarthritis 
b. Avascular necrosis 
c. Legg Perthes 
d. Rheumatoid Arthritis 
e. Diastrophic variant 
f. Fracture of the pelvis 
g. Fused hip 
h. Slipped capital epiphysis 
i. 
Subcapital fractures 
j. 
Traumatic arthritis 
Patients aged over 20 years old. 
Patients with limited co-morbidity – ASA I – III 
Patients must be able to understand instructions and be willing to return for follow-up 
Patients willing to provide blood and urine samples for metal ion analysis at follow-up  
 
Exclusion Criteria 
 
Pre-existing metal implants  
Absolute contraindications include: infection, sepsis, and osteomyelitis. 
Relative contraindications include:  
1) uncooperative patient or patient with neurologic disorders who are incapable of 
following directions,  
2) osteoporosis,  
3) metabolic disorders which may impair bone formation,  
4) osteomalacia,  
5) distant foci of infections which may spread to the implant site,  
6) rapid joint destruction, marked bone loss or bone resorption 
apparent on roentgenogram, and  
7) vascular insufficiency, muscular atrophy, or neuromuscular disease. 
8) pregnancy  
 
 

Rev.2 
 
ENDPOINTS 
 
SUBGROUP 1 
SUBGROUP 2 
PRIMARY ENDPOINTS* 
Survivorship at 2 year postop 
Dislocation (5 year postop), Range of 
Motion at 1 year postop. 
SECONDARY 
ENDPOINTS 
At all follow-up visits: 
Survivorship up to 10 year 
Harris Hip Score 
Radiographic Assessment 
Patient Satisfaction – EQ5D 
UCLA 
Complications including revisions 
 
At all follow-up visits: 
Survivorship up to 10 year (for 
Magnum arm) 
Harris Hip Score. 
Radiographic Assessment 
Patient Satisfaction – EQ5D 
UCLA 
Complications including revisions 
Metal Ion release 
MRI assessment to all available 
patients at 5 year follow-up. 
ADDITIONAL IMAGE ASSESSMENT FOR 
SYMPTOMATIC PATIENTS 
*For sample size calculations. 
 
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. 
 
Primary Endpoint  Accumulative Dislocation Rate at 5 year postoperative 
Superiority test – time to event 
 
Null Hypothesis:  
 
H0  
pt = pc 
 
Alternative Hypothesis: 
Ha  
pt = pc + d 
 
 
pt  = accumulative dislocation rate (1.8%)[2] in the trial group (Magnum) at 5 year 
postoperative. 
  
 
pc = accumulative dislocation rate (6.5%)[2] in the control group (M2A Taper) at 5 year 
postoperative. 
 
α = 0.025 
 
Significance Level (97.5% confidence) 
 
β = 0.20 
 
80% Power 
 
Z1-a/2 = 2.24 
Z1- β = 0.84 
 
N = 150 per group.  
 
Due to nature of this endpoint (occurrence of dislocation), it is not expected there will 
be significant lost to follow-up and patients usually come back to their operating 
surgeons for complications if any. 
 
 
 
 
 

Rev.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 at 1 year postoperative. 
  
 
μc: mean of ROM in the control group at 1 year postoperative. 
 
α = 0.025 
 
Significance Level (97.5% confidence) 
 
β = 0.20 
 
80% Power 
 
Z1-a/2 = 2.24 
Z1- β = 0.84 
 
d = 3.3 (degrees) 
Clinically Relevant Difference in ROM based on literature. 
 
ξ = 7.1 
 Estimate standard deviation of ROM at 1 year postoperative. 
This value is based on results (preop and 1 year postop) from 
literature 
 
N = 95 (including 7.5% lost to follow-up) per group 
 
 
RANDOMIZATION 
Patients will be randomized to receive M2A Magnum (trial group), or M2A Taper 
(control group). Patients have an equal opportunity of being assigned to the trial group 
or control group. Specifically: 
 
In case of unilateral patients, the affected side of hip will be randomized to one of two 
groups. In case of bilateral patients, both sides of hip will be randomized to the same 
device (M2A Taper or M2A Magnum).  
 
The randomization will occur via a random number generator (manual or computer). 
Block randomization will be used. Blocks of K patients will be created where K = 4. 
The possible sequences are AABB, BBAA, ABAB and BABA.  Two sets of 
randomization blocks will be followed by unilateral and bilateral patients respectively.  
For unilateral patients, A or B represents the device assigned to affected side of the hip. 
For bilateral patients, A or B represents the device assigned to both affected sides of 
the hip. 
 
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 5 sites recruiting 150 Magnum cases and 150 M2A Taper cases.  
 
 
 

Rev.2 
 
PARTICIPANT DATA MANAGEMENT 
 
The following table summarizes data collection required during the course of the study. 
 
 
PRE
-OP 
OP 
IMMEDIATE 
POST-OP 
3 
MO 
6 
MO 
1 
YR 
2 
YR 
3 
YR 
4 
YR 
5 
YR 
7 
YR 
10  
YR 
Informed 
Consent 
X 
 
 
 
 
 
X* 
 
 
 
 
 
Demographic 
and Historical 
Record 
X 
 
 
 
 
 
 
 
 
 
 
 
Operative 
Record 
 
X 
 
 
 
 
 
 
 
 
 
 
Metal ion 
concentrations 
in blood and 
urine 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Renal function 
(Creatinine 
Clearance Test) 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Harris Hip Score 
(Including ROM) 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
X 
Postoperative 
Thigh Pain 
 
 
 
X 
X 
X 
X 
 
 
X 
 
X 
EQ5D 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
UCLA Activity 
Score 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Radiographic 
Assessment 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
MRI 
Assessment 
 
 
 
 
 
 
 
 
 
X 
 
 
Additional 
Image 
Assessment 
(MRI / CT) 
As needed 
(for symptomatic patients only: having pain/discomfort on hip, higher ion 
concentration than 7ppb or suspect of ARMD etc) 
Complications & 
Revisions 
Anytime 
* Informed consent will be obtained at the time of 2 year follow-up to continue to 
participation of the study. 
 
METAL ION ANALYSIS 
Blood (serum) and urine will be collected at predetermined follow-up periods (3m, 6m, 
1y, 2yr[3-5], , 3y, 4y, 5y, 7 yr and 10y) to measure metal ion levels released (Co and Cr) 
from the articulating surfaces of M2A Magnum or M2A Taper cases. To create a 
baseline, blood (serum) and urine samples will also be taken preoperatively.  
 
All patients agree to the invasive procedure of giving blood and will provide blood and 
urine samples for measurement of metal ions pre-operatively. Patients with an existing 
metal implant or fixation device will be excluded. The analysis of metal ion 
concentrations within both blood and urine will be conducted. Blood and urine sample 
collection and metal ion analysis follow the protocol included in the Appendix I. 
 
 Metal ion analysis will be conducted separately for unilateral and bilateral patients. 
 
 

Rev.2 
 
 
RENAL FUNCTION ANALYSIS 
 
Creatinine and creatinine clearance tests measure the level of the waste product 
creatinine in your blood and urine. These tests tell how well your kidneys are working. 
The substance creatine is formed when food is changed into energy through a process 
called metabolism. Creatine is broken down into another substance called creatinine, 
which is taken out of your blood by the kidneys and then passed out of your body in 
urine. See a picture of the kidneys. 
Creatinine is made at a steady rate and is not affected by diet or by normal physical 
activities. If your kidneys are damaged and cannot work normally, the amount of 
creatinine in your urine goes down while its level in your blood goes up. 
A creatinine clearance test measures how well creatinine is removed from your blood 
by your kidneys. A creatinine clearance test gives better information than a blood 
creatinine test on how well your kidneys are working. A creatinine clearance test is 
done on both a blood sample and on a sample of urine. eGFR /Creatinine clearance 
will be calculated, analyzed as described in Guideline for Chronic Kidney Disease 
(published by Japanese Society for Nephrology).[7]  Renal function analysis will follow 
the protocol in Appendix I. All patients entered into the study agree to the invasive 
procedure of giving blood and urine samples for measurement of creatinine at 
preoperative and various postoperative visits. 
 
Renal function will be conducted separately for unilateral and bilateral patients. 
 
PARTICIPANT EVALUATION SCHEDULES 
 
All study Participants are expected to return for clinical, metal ion analysis 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 months follow-
up 
± 1 month 
2-4 
6 month follow-up 
± 1 month 
5-7 
1 year follow-up 
± 2 months 
10-14 
2 year follow-up 
± 2 months 
22-26 
3 year follow-up 
± 3 months 
33-39 
4 year follow-up 
± 3 months 
45-51 
5 year follow-up 
± 3 months 
57-63 
7 year follow-up 
± 3 months 
81-87 
10 year follow-up 
± 3 months 
117 - 123 
 

Rev.2 
 
 
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 hip 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 
 
Radiographic Views 
The study requires a full pelvic anteroposterior (AP) view and a lateral view.  
 
Assessment Procedure 
Assessments will be recorded on the radiographic assessment form at Immediately post-op, 
3months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 7 years and 10 years.  
 
The radiographic films will be marked for measurements as described in the following 
“Measurement angles and reference points” section for immediate post-operative time period 
only.  
The immediate post-operative film will be used as an index (bench mark) for subsequent 
follow-up assessments. 
 
The radiographic assessment definitions are as follows: 
 
Full-pelvic Anteroposterior (AP) Radiograph: This radiographic view will be obtained with the 
patient placed in the supine position with the bilateral hip joint in a neutral position. The 
radiation beam must be centered on the pubic symphysis. The X-ray should include the total 
prosthesis, including the entire length of the femoral stem.  
 
 
Lateral Radiograph: A cross-table lateral radiograph will be obtained with the patient placed in 
the supine position with the contralateral hip flexed to 90o or maximally. The direction of the 
radiation beam is parallel to the examination table and is at 45o to the long axis of the body.  
Again, the X-ray should include the total prosthesis, including the entire length of the femoral 
stem.  
 
Radiolucency or Radiolucent Lines: A radiographic clearing or line not exceeding 2 mm in 
width at the bone/implant interface.  
 
Osteolysis: A progressive radiolucency greater than 2 mm in width in one or more zones not 
present on immediate post-operative radiographs and/or a peri-acetabular bony destructive 
lesion that is progressive in nature. 
 
Migration: Medial or superior movement of the acetabular component exceeding 4 mm as 
compared to immediate post-operative radiographs. 

Rev.2 
 
Subsidence: A vertical settling or sinking of the femoral component exceeding 5 mm as 
compared to immediate post-operative radiographs.  
 
Ectopic (Heterotopic) Ossification: Abnormal bone formation following surgery or trauma. 
 
Heterotopic Ossification Classification: The Brooker classification is utilised to categorise the 
various levels of ossification: 
• 
Class I: represents islands of bone w/in soft tissues about hip  
• 
Class II: includes bone spurs in pelvis or proximal end of femur leaving at least 1 cm 
between the opposing bone surfaces 
• 
Class III: represents bone spurs that extend from pelvis or the proximal end of femur, 
which reduce the space between the opposing bone surfaces to less than 1 cm 
• 
Class IV: indicates radiographic ankylosis of the hip 
 

Rev.2 
Measurement angles and reference points 
 
Acetabular angle of inclination (α) 
The acetabular angle of inclination (α) is measured on an AP pelvic radiographic view. An 
inter-teardrop line and an intersecting line across the outer edges (medial and lateral edges) 
of the acetabular cup are drawn. The angle of inclination is measured at the intersection of 
these two lines (see Figure 1). An angle of less than 60o is considered normal and the change 
in position is measured over time. As stated in the clinical investigation plan, a change in 
angle of inclination of more than 4o over time will be considered a failure.  
 
Acetabular cup position and migration (superior and medial) 
The acetabular cup migration is measured on an AP pelvic radiograph (see Figure 1). The cup 
position in both the superior-inferior and medial-lateral direction must be measured from the 
immediate post-operative radiograph. The measurements will be made using the method 
described by Nunn et al 1. To determine the acetabular position in the superior-inferior 
direction (Ay), the vertical distance between the centre of the cup (determined by bisecting the 
intersecting line across the outer edges of the acetabular cup) and the inter-teardrop line is 
measured. The medial-lateral position (Ax) is the measured horizontal distance between the 
point x, directly below the centre of the cup, and the nearest teardrop. All measured distances 
must be corrected for magnification. Migration of the acetabular component in both the 
superior and medial direction will be calculated by comparing the change in distance over time. 
A change in the distance of more than 4 mm will be considered a failure.      
 
 
Figure 1. Measurement of acetabular component position, angle of inclination and migration.  
 
 Acetabular cup version angle (β) 
The version angle of the acetabular cup (β) will be measured on the lateral X-ray using the 
method described by Arai et al2. A line perpendicular to the horizontal plane of the radiograph 
                                                 
1 Nunn D, MAR Freeman, PF Hill and SJW Evans, “The measurement of migration of the acetabular 
component of hip prostheses”. The Journal of Bone and Joint Surgery 71B (4), pp 629-631, 1989. 
2 Arai N, S Nakamura and T Matsushita, “Difference between 2 measurement methods of version 
angles of the acetabular component”. The Journal of Arthroplasty Vol 22 No 5, pp 715-720, 2007. 

Rev.2 
and an intersecting line across the outer edges (medial and lateral edges) of the acetabular 
cup are drawn. The version angle () is measured at the intersection of these two lines (see 
Figure 2). This technique allows an estimation of anteversion (shown in Fig 2), neutral position 
or retroversion of the acetabular component3.  
 
 
Figure 2. Measurement of acetabular cup version angle. 
 
 
                                                 
3 Woo RY and BF Morrey, “Dislocations after total hip arthroplasty”. The Journal of Bone and Joint 
Surgery 64, pp 1295-1306, 1982. 

Rev.2 
 Femoral stem position and subsidence 
To determine the position of the femoral stem the immediate post-operative radiograph will be 
measured. The measurements will be made using a modified version of the method described 
by Sutherland et al4. The vertical plane is parallel with the femoral canal. The vertical distance 
from the level of the superior tip of the greater trochanter to the level of the centre of the 
femoral head (Fy1) and the vertical distance from the shoulder of the femoral stem and the 
most proximal point on the lesser trochanter (Fy2) will be measured to determine the vertical 
position of the femoral stem (see Figure 3). The measured distances must be corrected for 
magnification. Subsidence of the femoral stem will be calculated by comparing a change in the 
vertical distances measured over time and a change in distance of greater than 5 mm will be 
considered a failure. 
 
 
Figure 3: Measurement of femoral stem position and subsidence. 
                                                 
4 Sutherland CJ, AH Wilde, LS Borden and KE Marks, “A ten-year follow-up of one hundred consecutive 
Muller curved-stem total hip-replacement arthroplasties”. The Journal of Bone and Joint Surgery 64A, 
pp 970-982, 1982.  

 
Rev.2 
Radiographic Radiolucency Measurements 
Radiolucencent lines at the bone-implant interface and evidence of osteolysis will be measured on 
both AP and lateral radiographs. The standard fourteen (14) Gruen zones will be used to record 
radiolucency surrounding the femoral component and the three (3) acetabular zones described by 
DeLee and Charnley will be used to record radiolucency surrounding the acetabular component 
(see Figure 4). The apparent thickness of the radiolucency within these zones will be recorded. 
Evidence of osteolysis (radiolucency > 2mm thickness) in the peri-prosthetic tissue of the 
acetabular or femoral component will be considered a failure.  
 
 
Figure 4: Radiographic zones for assessment of femoral and acetabular component radiolucency. 
 
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. 
 
• 
Ethical Committee Approval Information. 

 
Rev.2 
 
• 
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 THA w/ Magnum Acetabular, which is intended to 
help the participant gain mobility and decrease pain.  Risks associated with this hip system 
include general surgical and hip 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 Magnum System 
and, as stated above, may occur with any total joint replacement surgery. 
 

 
Rev.2 
As with any joint replacement post-operative activity, limitations may be imposed depending 
upon the participant’s age, general health, baseline (pre-operative) activity level and 
baseline (pre-operative) condition of the hip and other joints. 
 
 
Minimization of Risk 
 
With the increased understanding of failure modes for total hip arthroplasty, 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 study 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. 
 
Reference: 
 
1. Australian Orthopaedic Association (AOA) Hip and Knee Arthroplasty Report 2008. 
2. Daniel J. Berry, Marius von Knoch, Cathy D. Schleck and William S. Harmsen, Effect of 
Femoral Head Diameter and Operative Approach on Risk of Dislocation After Primary Total 
Hip Arthroplasty,  J Bone Joint Surg Am. 2005;87:2456-2463 
3. Engh CA Jr, MacDonald SJ, Sritulanondha S, Thompson A, Naudie D and Engh CA; 2008 
John Charnley award: metal ion levels after metal-on-metal total hip Arthroplasty: a 
randomized trial. Clin. Orthop. Relat. Res. 2009 Jan 467 (1): 101-11. 
4. Daniel J, Ziaee H, Pradhan C, Pynsent PB, McMinn DJ. Blood and urine metal ion levels in 
young and active patients after Birmingham hip resurfacing arthroplasty: four-year results of 
a prospective longitudinal study. JBJS Br. 2007 Feb;89(2):169-73 
5. Antoniou J, Zukor DJ, Mwale F, Minarik W, Petit A, Huk OL. Metal ion levels in the blood of 
patients after hip resurfacing: a comparison between twenty-eight and thirty-six-millimeter-
head metal-on-metal prostheses. JBJS Am.2008 Aug;90 Suppl 3:142-8. 
6. MacDonald SJ, McCalden RW, Chess DG, Bourne RB, Rorabeck CH, Cleland D, Leung F; 
Metal-on-metal versus polyethylene in hip arthroplasty: a randomized clinical trial. Clin 
Orthop Relat Res. 2003 Jan;(406):282-96. 
7. Guideline for Chronic Kidney Disease (CKD) 
http://www.jsn.or.jp/ckd/pdf/CKD01.pdf 
 
 
 
Appendix I  
 
Metal Ion Level and Renal Function Analysis Protocol (To be determined with SRL)