A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres (HISTORIC)

Osteoarthritis, Hip Clinical Trial

— HISTORIC  

Official title:

A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02435420
• Other study ID #: 14-4542-03
• Status: Terminated
• Phase: N/A
• First received: April 30, 2015
• Last updated: February 1, 2018
• Start date: August 1, 2015
• Est. completion date: November 9, 2017

Study information

• Verified date: February 2018
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 9, 2017
• Est. primary completion date: November 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Degenerative
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• EMPERION Modular Primary Stem
Primary total hip arthroplasty using the EMPERION Modular Primary Stem

Locations

Country	Name	City	State
Australia	Dubbo Base Hospital	Dubbo	New South Wales
Australia	Dubbo Private Hospital	Dubbo	New South Wales
Australia	Epworth Centre	Melbourne	Victoria
Australia	Mater Health Services	South Brisbane	Queensland
Australia	Hip and Knee Clinic at Sydney Olympic Park	Sydney	New South Wales
Australia	North Shore Private Hospital	Sydney	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	John Flynn Hospital	Tugun	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship of stem		5 years
Secondary	Revision for any reason		5 years
Secondary	Radiographic Assessment	Radiographic problems, component orientation, radiolucencies, migration, osteolysis, stress shielding, subsidence	5 years
Secondary	Harris Hip Score		5 years
Secondary	Adverse Events		5 years