Post Market Clinical Follow-Up Study of the Zimmer Stafit Acetabular System. A Multicenter, Prospective, Non-controlled Study
Conditions: Osteoarthritis, Hip, Fracture of Hip, Avascular Necrosis of Hip, Dislocated Hip, Osteonecrosis, Post-traumatic; Arthrosis, Rheumatoid Arthritis, Subluxation Hip
Sponsor: Zimmer Biomet

Stafit Acetabular System 
 
2011-11-14 - REV. 2 
Protocol # 09-H07 
 
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Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular 
System 
A multicenter, prospective, non-controlled study 
 
 
 
 
 
 
PROTOCOL NO. 09-H07 
 
 
NCT NUMBER: NCT04079114 
 
 
 
PROTOCOL VERSION: 
2011-11-14 - REV. 2 
 
 
 
 
 
 
 
 
STUDY SPONSOR 
 
ZIMMER GMBH 
SULZERALLEE 8 
P.O. BOX 
CH-8404 WINTERTHUR 
SWITZERLAND 
 
 
 
 
 
 

Stafit Acetabular System 
 
2011-11-14 - REV. 2 
Protocol # 09-H07 
 
Page 2 of 3 
 
Title:
Post Market Clinical Follow-Up Study of the Zimmer Stafit Acetabular 
System. A multicenter, prospective, non-controlled study. 
Sponsor:
Zimmer GmbH 
Objectives/
Endpoints:
The objective of this study is to obtain outcome data on the Zimmer 
Stafit Acetabular 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 implant survival, and to confirm the safety and performance of the 
Zimmer Stafit Acetabular System. 
Primary endpoints: 
• 
implant survival (Kaplan Meier) 
• 
dislocation rate at 2 years 
Secondary endpoints: 
• 
pain and functional performance (HHS) 
• 
safety (adverse events) 
• 
radiographic parameters 
Indication/Target 
Population:
Patients, suffering from severe hip pain and disability, requiring primary 
total hip arthroplasty with high risk of dislocation, who meet the 
inclusion/exclusion criteria (see Section Error! Reference source not 
found.). 
Study Design:
Multi-center, prospective, non-controlled. 
Clinical Phase:
Post-market 
Number of subjects:
A total of 250 patients will be enrolled into the study. 
Length of Study:
11.5 years (18 months enrollment plus 10 years follow-up): follow-up 
visits at 6-12 weeks, 1, 2, 3, 5, 7 and 10 years post-operatively. 
Study Device:
Stafit Acetabular System  
 
 
Scores:
Harris Hip Score (HHS) 
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.  
Documentation:
Paper 
 
 
 
 

Stafit Acetabular System 
 
2011-11-14 - REV. 2 
Protocol # 09-H07 
 
Page 3 of 3 
 
 
 
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 Stafit Acetabular 
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. 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.