Continuum™ Metal Bearing System in Total Hip Arthroplasty- A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Conditions: Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Post-traumatic; Arthrosis, Total Hip Arthroplasty
Sponsor: Zimmer Biomet

 
 
Continuum™ Metal Bearing System in Total Hip Arthroplasty 
Protocol number: 09-H03 
 
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Continuum™ Metal Bearing System in Total Hip 
Arthroplasty  
A multi-center, prospective, non-controlled post 
market surveillance study 
 
 
Protocol number: 09-H03 
Protocol date: 30 August 2012 
NCT number: 03382652 
 
 
 

 
 
Continuum™ Metal Bearing System in Total Hip Arthroplasty 
Protocol number: 09-H03 
 
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STUDY SYNOPSIS 
 
Complete Protocol Title 
Continuum™ Metal Bearing System in Total Hip 
Arthroplasty - A multi-center, prospective, non-controlled 
post market surveillance study 
Protocol Number 
09-H03 
Short Protocol Title 
Continuum™ Metal Bearing System in Total Hip 
Arthroplasty 
Sponsor 
Zimmer Biomet GmbH 
Manufacturer 
Zimmer Biomet GmbH 
Study Device(s) 
Investigational devices 
1. Continuum™ Acetabular Shell 
2. Metasul® Taper Liner 
3. Metasul Femoral Head 
Combination device 
Zimmer® M/L Taper Hip Stem 
Study Objectives/Endpoints 
The objectives of this study are to obtain survival and 
outcome data on the Continuum Metal Bearing System 
when used in primary total hip arthroplasty. This will be 
done by analysis of standard scoring systems, radiographs 
and adverse event records. Data will be used to monitor 
pain, mobility and survivorship, and to confirm the safety 
and performance of the Continuum Metal Bearing System. 
Safety will be evaluated by monitoring the frequency and 
incidence of adverse events. 
Performance will be determined by comparing the overall 
pain and functional performances, survivorship, subject 
quality-of-life and radiographic parameters of study 
subjects who received the Continuum Metal Bearing 
System. 
Pain and functional performance will be measured using 
the Harris Hip Score, survivorship will be based on removal 
or intended removal of the device, subject quality-of-life 
will be determined by evaluation of the SF-12, and 
radiographic parameters by analysis of x-rays. 
In addition, metal ion levels (cobalt, chromium and 
titanium) and renal function (BUN, Creatinine and GFR) will 
also be analyzed preoperatively and again at 6 months, 1, 
2 and 5 years. 
Indications/Target Population 
Patients, suffering from severe hip pain and disability 
requiring total hip arthroplasty. 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
• 
Patient is 18 to 75 years of age, inclusive. 
• 
Patient is skeletally mature. 

 
 
Continuum™ Metal Bearing System in Total Hip Arthroplasty 
Protocol number: 09-H03 
 
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• 
Patient qualifies for primary unilateral or bilateral 
total hip arthroplasty (THA) based on physical 
exam and medical history including the following: 
o Avascular necrosis (AVN) 
o Osteoarthritis (OA) 
o Inflammatory arthritis (i.e. Rheumatoid 
arthritis) 
o Post-traumatic arthritis 
• 
Patient has no history of previous prosthetic 
replacement device (any type, including surface 
replacement arthroplasty, endoprosthesis, etc.) of 
the affected hip joint(s). 
• 
Patient has a Harris Hip Score <70 in the affected 
hip 
• 
Patient is willing and able to provide written 
informed consent. 
• 
Patient is willing and able to cooperate in the 
required post-operative therapy. 
• 
Patient is willing and able to complete scheduled 
follow-up evaluations as described in the Informed 
Consent. 
• 
Patient has participated in the Informed Consent 
process and has signed the Ethics Committee 
approved informed consent. 
 
Exclusion Criteria 
• 
The patient is: 
o A prisoner 
o Mentally incompetent or unable to 
understand what participation in the study 
details. 
o A known alcohol or drug abuser 
o Anticipated to be non-compliant. 
• 
The patient has a neuromuscular disorder, vascular 
disorder or other conditions that could contribute 
to prosthesis instability, prosthesis fixation failure, 
or complications in postoperative care. 
• 
The patient has a neurologic condition in the 
ipsalateral or contralateral limb which affects 
lower limb function. 
• 
The patient has a diagnosed systemic disease that 
could affect his/her safety or the study outcome. 
• 
The patient is known to be pregnant. 
• 
The patient is unwilling or unable to give consent, 
or to comply with the follow-up program. 
• 
The patient has received an investigational drug or 
device within the previous 6 months. 
• 
The patient has an active or latent infection in or 
about the affected hip joint or an infection distant 
from the hip joint that may spread to the hip 

 
 
Continuum™ Metal Bearing System in Total Hip Arthroplasty 
Protocol number: 09-H03 
 
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hematogenously. 
• 
The patient has insufficient bone stock to fix the 
component. Insufficient bone stock exists in the 
presence of metabolic bone disease (i.e. 
osteoporosis), cancer, and radiation. Note: Dual 
Energy X-ray Absorptiometry (DEXA) may be used 
to assess the presence of adequate bone stock. 
• 
The patient has known local bone tumors and/or 
cysts in the operative hip. 
• 
The patient has a known allergic reaction to one or 
more of the implanted material. 
• 
The patient is Grade III obese with a Body Mass 
Index (BMI) ≥ 40. 
• 
The patient has osteoradionecrosis in the affected 
hip joint 
• 
Kidney insufficiency (Kidney insufficiency will be 
determined based on eGFR value.) 
Study Design 
Multi-center, prospective, non-controlled. 
Clinical Phase 
Post-market 
Sample Size  
A total of 100 patients will be enrolled into the study.  
Length of Study 
11 years (1 years of enrollment (all sites) and 10 years of 
follow-up) 
Materials and Methods 
Case report forms will be completed at Pre-op, Surgery, 
Immediate Post-op, and the 6 weeks, 6 months, 1, 2, 3, 5, 
7 and 10 years intervals. 
Data Collection 
Electronic 
Statistical Reporting 
Data collected will be summarized and reported to each 
participating investigator.  Statistical analysis will be 
conducted by Zimmer Biomet or its designee. Survivorship 
will be evaluated using Kaplan-Meier. 
Scores/Performance Assessments 
Evaluations will be made using the Harris Hip Score (HHS), 
SF-12, EuroQol (EQ-5D) and Oxford Hip Score (optional). 
Standards 
The PMCF is compliant with the below: 
• 
ISO 14155 Standard for the Clinical Investigation of 
Medical Devices (part 1 and 2) 
• 
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. . 
 
 

 
 
Continuum™ Metal Bearing System in Total Hip Arthroplasty 
Protocol number: 09-H03 
 
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STATISTICAL ANALYSIS PLAN 
Statistical Method 
Data collected in the study will be summarized descriptively. Descriptive summaries will be used for 
the basis of all study reports, including a summary of the clinical performance of the Continuum 
Metal Bearing System in primary total hip arthroplasty, and may be used for reports and to support 
presentations and publications as needed. 
Summaries will routinely describe categorical data as counts and percentages, and ninety-five 
percent confidence limits will be generally used to assess differences over time. Routine summaries 
describing continuous data will be in the form of means, medians, standard deviations, minima, and 
maxima, and ninety-five percent confidence intervals will be used to contrast differences. 
Routine summaries of implant survival will be described using the Kaplan-Meier method and these 
will be accompanied with the corresponding crude rates (expressed as percentages). Routine 
summaries of complication data will be in the form of frequencies and percentages. Summaries may 
be further generated for strata within the study population, (e.g., males and females, at different cut-
points in the body mass index continuum, etc.). 
Patient confidentiality will be protected at all times, and patient identifiers will not be included in 
study summaries.