A Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data on the Exceed ABT Acetabular Cementless Cup System (Implants and Instruments)
Conditions: Osteoarthritis, Rheumatoid Arthritis, Correction of Functional Deformity
Sponsor: Zimmer Biomet

 
GBMET.CR.EU37 Protocol Synopsis and Statistical Analysis Plan 
CIP date: August 2018, CIP Rev: 1 
 
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CLINICAL INVESTIGATION PLAN 
CIP ID: BMETEU.CR.EU37 
 
A Post-market Clinical Follow-up Study to Provide 
Safety, Performance and Clinical Benefits Data on the 
Exceed ABT Acetabular cementless cup system 
(Implants and Instruments)  
NCT number: NCT04255394 
Revision 1 
August 2018 
 
 
 
  
 
 
 
 
STUDY SPONSOR 
 
Zimmer GmbH 
Sulzerallee 8 
P.O. Box 
CH-8404 Winterthur 
Switzerland 
Tel. +41 52 262 60 70 
 

 
GBMET.CR.EU37 Protocol Synopsis and Statistical Analysis Plan 
CIP date: August 2018, CIP Rev: 1 
 
2 
 
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STUDY SYNOPSIS 
Title: 
 
A Post-market Clinical Follow-up Study to provide safety, performance and 
clinical benefits data on the Exceed ABT acetabular cup (implants and 
instruments) when used in combination with CoC or CoP bearing options. 
CIP ID: BMETEU.CR.EU37 
Sponsor: Zimmer GmbH 
Manufacturer: Biomet UK Ltd  
Aim: To collect survivorship and clinical outcomes long-term data confirming 
safety, performance and clinical benefits of the Exceed ABT cementless cup 
when used in combination with ceramic and polyethylene articulating 
liners.   
Objectives: Primary Objectives: 
Clinical performance - as measured by clinical score data 
(HHS, WOMAC and Oxford Hip Score), radiographic 
assessments and survivorship which will be based on 
removal of the device. 
Secondary Objectives: 
 
Safety will be evaluated by monitoring incidence of adverse 
events. 
Indication/ 
Target 
Population: 
Indication: 
1. Non- inflammatory degenerative joint disease including oste-
oarthritis, avascular necrosis & post – traumatic arthritis.   
2. Rheumatoid arthritis  
3. Correction of functional deformity 
4. Revision of failed joint reconstruction or treatment 
5. Treatment of femoral neck and trochanteric fractures of the 
proximal femur with femoral head involvement and which are 
unmanageable using other techniques.   
 
          Population:  
 
          Male and Female ≥18 years 
Inclusion/Exclusi
on Criteria 
Inclusion Criteria: 
 
1. 
Patients who are capable of understanding the doctor’s 

 
GBMET.CR.EU37 Protocol Synopsis and Statistical Analysis Plan 
CIP date: August 2018, CIP Rev: 1 
 
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explanations, following his instructions and are able to participate in 
the follow-up program 
2. 
Patient who gave verbal consent to take part in the study at 
study commencement  and written consent retrospectively at 10 years 
follow-up by signing the “ GDPR Pa-tient Consent Form” 
3. 
Age: => 18 years 
4. 
Male and Female 
5. 
Non- inflammatory degenerative joint disease including 
osteoarthritis, avascular ne-crosis & post – traumatic arthritis   
6. 
Rheumatoid arthritis,  
7. 
Correction of functional deformity 
8. 
Revision of failed joint reconstruction or treatment  
9. 
Treatment of femoral neck and trochanteric fractures of the 
proximal femur with femoral head involvement and which are 
unmanageable using other techniques   
 
Exclusion Criteria: 
 
1. Infection, sepsis, and osteomyelitis  
2. Patients who are unwilling or unable to give consent, or to com-
ply with the follow-up program. 
3. The patient is known to be pregnant or breastfeeding 
4. Any vulnerable subjects (= individuals whose willingness to vol-
unteer in a clinical investigation could be unduly influenced by 
the expectation, whether justified or not, of benefits associated 
with participation or of retaliatory response from senior mem-
bers of a hierarchy in case of refusal to participate)  
5. Uncooperative patient or patient with neurologic disorders who 
are incapable of following instruction   
6. Osteoporosis 
7. Metabolic disorder which may impair bone formation 
8. Osteomalacia  
9. Local and distant foci of infection 
10. Rapid joint destruction, marked bone loss or bone resorption 
apparent on roentgenogram  
11. Vascular insufficiency, muscular atrophy, or neuromuscular 
disease 
12. Skeletal immaturity  
13. Morbid obesity  

 
GBMET.CR.EU37 Protocol Synopsis and Statistical Analysis Plan 
CIP date: August 2018, CIP Rev: 1 
 
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14. Foreign body sensitivity. Where suspected, material sensitivity 
tests are to be made prior to implantation.  
15. Any condition that may interfere with the survival of the im-
plant such as Paget’s disease, Charcot’s disease, sickle cell 
anaemia or traits, lower extremity muscular atrophy or neuro-
muscular disease’ 
Study Design: A single-center, cohort observational clinical outcomes study 
Clinical Phase: Post-market 
Number of 
Subjects: 
676 
Length of Study: 13 years (3 years enrollment plus 10 years follow-up): Post-operative 
follow-up visits at: 1, 3, 5, 7 and 10 years.  
Start date: Nov. 2007 
Study Device: Exceed ABT Acetabular System - a multiple bearing option system 
(implants and instrumentation)   
Scores: Harris Hip Score, Womac Hip Score, Radiographic Assessment & 
Oxford Hip Score 
Documentation: Paper / Electronic  
 
 
 
 

 
GBMET.CR.EU37 Protocol Synopsis and Statistical Analysis Plan 
CIP date: August 2018, CIP Rev: 1 
 
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STATISTICAL ANALYSIS PLAN 
 
2.1 Sample Size 
 
This study is a non-comparative case-series, therefore no sample size determination was 
performed. The aim is to collect clinical outcomes data on the Exceed ABT cementless cup. 
 
 
2.2 Statistical Analysis 
 
Data collected in the study will be summarized descriptively. Descriptive summaries will be the basis 
of study reports. 
Continuous data (e.g. age) will be summarized through means, medians, standard deviation, 
minimum, maximum and 95% confidence intervals (CIs) over time periods of interest. Categorical 
data (e.g. gender) will be summarized using counts, percentages and 95% confidence limits over time 
periods of interest. Summaries of implant-related revision rates and complication data will be 
presented as frequencies and percentages. Subgroup summaries will be generated as needed either 
by strata within the study population (e.g. male vs. female) or by different cut-points (e.g. body mass 
index (BMI) ranges). Patient confidentiality will be protected at all times, and patient identifiers will 
not be included in data summaries.