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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02435420
Other study ID # 14-4542-03
Secondary ID
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
Health authority
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

Study Design


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
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