Prospective, Multi - Centre Clinical Evaluation of the Performance and Safety of the HYPERION Hip Endoprosthesis System in Defect Reconstruction
Conditions: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities, Pseudoarthrosis, Revision of Endoprosthesis-treated Hips, Fracture, Proximal Humeral, Provision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies), Femur Fracture, Pseudarthrosis, Trochanteric Fractures, Bridging of Large Bone Defects, Revisions
Sponsor: Zimmer Biomet

CLINICAL INVESTIGATION PLAN 
 
 
Prospective, multi - centre clinical evaluation of 
the performance and safety of the HYPERION 
hip endoprosthesis system in defect 
reconstruction 
 
 
Protocol version: Rev.03; 4th June 2015 
 
Protocol Number: BMETEU.CR.EU79.10 
 
NCT Number: NCT03382665 
 
 
 
 
 
 
 
 
STUDY SPONSOR 
 
Zimmer GmbH 
Sulzerallee 8 
P.O. Box 
CH-8404 Winterthur 
Switzerland 
 
 
 
 

Study Summary 
Title: Prospective, multi - centre clinical evaluation of the performance and 
safety of the HYPERION hip endoprosthesis system in defect 
reconstruction 
Sponsor: Zimmer GmbH 
Objectives/ 
Endpoints 
 
The data collected from this post-market clinical follow up study will 
serve the purpose of confirming long-term safety and performance of 
the Hyperion system. To this aim, the Hyperion system will be 
evaluated using standard scoring systems, radiographs and the 
reporting of adverse events. Patients having received the Hyperion 
hip replacement stem will be followed up after 1 week, 3 month, 6 
month, 1, 2 and 5 years assessing clinical and radiographic 
outcomes. In addition, after 7- and 10- years the patients will be 
asked to fill in a questionnaire recording the patients mid-to long-
term clinical satisfaction. 
Primary endpoints: 
1. Merle d‘Aubigné score 
Endpoint: Merle d‘ Aubigné Score increase of min. 4 points at 2 
years post surgery, compared to the pre-operative score points (< 12 
points). 
 
2. Implant survival at 2 years (+/- 2 months) 
 
3. Western Ontario and McMaster Universities Osteoarthritis 
Index (WOMAC) scores 
Endpoint: Decrease in min. 25 points in the WOMAC Score 
compared to the pre-operative determined points (WOMAC Score > 
25 points pre-operative). The primary outcome measure is at 2 years 
(+/- 2 month). 
Indication/ 
Target 
Population: 
Patients, suffering from severe hip pain and disability requiring total 
hip arthroplasty, who meet the inclusion/exclusion criteria  
Study Design: Multi-center, prospective, non-controlled  
Clinical Phase: Post-market 
Number of 
Subjects: 
A total of 70 patients will be enrolled 
 

Length of Study: 12 years  
Study Device: Hyperion System 
Clinical 
Assessments 
Merle d`Aubigné Score, WOMAC scores and radiographic 
assessments.  
Safety 
Assessments: 
Safety will be assessed by appropriate recording and reporting of 
adverse events throughout the study. All system components are CE 
marked and commercially available. 
Statistical 
Analysis 
Data collected will be summarized and reported to each participating 
Investigator. Statistical analysis is conducted by Zimmer or its 
designee. 
 
General 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 
HYPERION hip endoprosthesis system in defect reconstruction, 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. 
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, such as 
males/females, body mass index or primary diagnosis.