Clinical trial NCT02435420: A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres (HISTORIC)
Official title: A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis, Hip
Arthritis, Degenerative
Keywords: Total Hip Arthroplasty
EMPERION Modular Stem
Survivorship
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that have been implanted with the EMPERION modular primary stem for primary total hip arthroplasty.

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.

Detailed description: The main aim of the study is to demonstrate that there is no significant difference in survivorship at 5 years in the EMPERION™ primary stem compared to other primary stems for total hip arthroplasty.

Investigational site personnel will review and screen clinical records for potential subjects to be included in the study. Eligible patients will be contacted and follow-up status and implant revision status will be assessed at this initial contact. The subject will be given the option to participate in a prospective 5-year on-site follow-up visit for which they will provide written informed consent. An HREC waiver of informed consent for study participation will be obtained for subjects who are lost to follow-up, deceased or are unwilling/unable to participate in a prospective on-site 5-year follow-up visit, allowing the inclusion of data from all patients implanted with the study device regardless of follow-up status and therefore eliminate selection bias.

Data will be collected retrospectively from the subject pre-surgery, during surgery, at discharge and at 1-year follow-up found in their medical files and prospective data will be collected from the subject's 5-year Follow-up visit and documented on specially designed Case Report Forms (CRFs).

Data to be collected include:

* Subject demographics
* Primary diagnosis for THA
* Additional relevant history and physical findings
* Post-operative follow-up findings at 1 and 5 years
* Radiological Assessment
* Revision by time points
* Adverse Events

Eligibility criteria: Inclusion Criteria:

1) Subject has undergone primary total hip arthroplasty with the EMPERION™ Modular hip system

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

Primary outcomes:
measure: Survivorship of stem
timeFrame: 5 years
Secondary outcomes:
measure: Revision for any reason
timeFrame: 5 years
measure: Radiographic Assessment
timeFrame: 5 years
measure: Harris Hip Score
timeFrame: 5 years
measure: Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
city: Dubbo
country: Australia
facility: Dubbo Base Hospital
state: New South Wales
city: Dubbo
country: Australia
facility: Dubbo Private Hospital
state: New South Wales
city: Sydney
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Hip and Knee Clinic at Sydney Olympic Park
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Health Services
state: Queensland
city: Tugun
country: Australia
facility: John Flynn Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Epworth Centre
state: Victoria
Study officials:
affiliation: John Flynn Private Hospital
name: Dr David Liu, BSc, M.B., B.S. F
role: PRINCIPAL_INVESTIGATOR
References: