Study Stopped
Commercial decision
A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres (HISTORIC)
HISTORIC
1 other identifier
observational
25
1 country
8
Brief Summary
This is a retro-prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in at least 156 subjects, at up to 10 sites in Australia, who have been implanted with the EMPERION™ Modular Hip System in primary THA procedures to assess its safety and efficacy over 5 years post-surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2015
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2017
CompletedFebruary 5, 2018
February 1, 2018
2.3 years
April 30, 2015
February 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survivorship of stem
5 years
Secondary Outcomes (4)
Revision for any reason
5 years
Radiographic Assessment
5 years
Harris Hip Score
5 years
Adverse Events
5 years
Study Arms (1)
EMPERION Modular Primary Stem subjects
All subjects have previously been implanted with the EMPERION Modular Primary Stem for primary total hip arthroplasty.
Interventions
Primary total hip arthroplasty using the EMPERION Modular Primary Stem
Eligibility Criteria
Subjects that have been implanted with the EMPERION modular primary stem for primary total hip arthroplasty.
You may qualify if:
- \) Subject has undergone primary total hip arthroplasty with the EMPERION™ Modular hip system
You may not qualify if:
- Subject received the EMPERION™ THA on the affected hip as a revision for a previously failed THA
- At the time of surgery, subject had an active infection or sepsis (treated or untreated)
- At the time of surgery, subject had presence of malignant tumor, metastatic or neoplastic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Dubbo Base Hospital
Dubbo, New South Wales, 2830, Australia
Dubbo Private Hospital
Dubbo, New South Wales, 2830, Australia
North Shore Private Hospital
Sydney, New South Wales, 2065, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
Hip and Knee Clinic at Sydney Olympic Park
Sydney, New South Wales, 2127, Australia
Mater Health Services
South Brisbane, Queensland, 4101, Australia
John Flynn Hospital
Tugun, Queensland, 4224, Australia
Epworth Centre
Melbourne, Victoria, 3121, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr David Liu, BSc, M.B., B.S. F
John Flynn Private Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 6, 2015
Study Start
August 1, 2015
Primary Completion
November 9, 2017
Study Completion
November 9, 2017
Last Updated
February 5, 2018
Record last verified: 2018-02