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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02435420




Registration number
NCT02435420
Ethics application status
Date submitted
30/04/2015
Date registered
6/05/2015
Date last updated
5/02/2018

Titles & IDs
Public title
A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres (HISTORIC)
Scientific title
A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres
Secondary ID [1] 0 0
14-4542-03
Universal Trial Number (UTN)
Trial acronym
HISTORIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Hip 0 0
Arthritis, Degenerative 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - EMPERION Modular Primary Stem

EMPERION Modular Primary Stem subjects - All subjects have previously been implanted with the EMPERION Modular Primary Stem for primary total hip arthroplasty.


Treatment: Devices: EMPERION Modular Primary Stem
Primary total hip arthroplasty using the EMPERION Modular Primary Stem
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survivorship of stem
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Revision for any reason
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Radiographic Assessment
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Harris Hip Score
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Adverse Events
Timepoint [4] 0 0
5 years

Eligibility
Key inclusion criteria
1) Subject has undergone primary total hip arthroplasty with the EMPERION™ Modular hip system
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject received the EMPERION™ THA on the affected hip as a revision for a previously failed THA
2. At the time of surgery, subject had an active infection or sepsis (treated or untreated)
3. At the time of surgery, subject had presence of malignant tumor, metastatic or neoplastic disease

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/11/2017
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [2] 0 0
Dubbo Private Hospital - Dubbo
Recruitment hospital [3] 0 0
North Shore Private Hospital - Sydney
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [5] 0 0
Hip and Knee Clinic at Sydney Olympic Park - Sydney
Recruitment hospital [6] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [7] 0 0
John Flynn Hospital - Tugun
Recruitment hospital [8] 0 0
Epworth Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2830 - Dubbo
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2127 - Sydney
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4224 - Tugun
Recruitment postcode(s) [6] 0 0
3121 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02435420
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr David Liu, BSc, M.B., B.S. F
Address 0 0
John Flynn Private Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02435420