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

NCT ID: NCT02435420

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2017-11-09

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

Conditions

Osteoarthritis, Hip; Arthritis, Degenerative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

EMPERION Modular Primary Stem subjects

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

EMPERION Modular Primary Stem

Intervention Type: DEVICE

Primary total hip arthroplasty using the EMPERION Modular Primary Stem

Interventions

EMPERION Modular Primary Stem

Primary total hip arthroplasty using the EMPERION Modular Primary Stem

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr David Liu, BSc, M.B., B.S. F

Role: PRINCIPAL_INVESTIGATOR

John Flynn Private Hospital

Locations

Dubbo Base Hospital

Dubbo, New South Wales, Australia

Dubbo Private Hospital

Dubbo, New South Wales, Australia

North Shore Private Hospital

Sydney, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

Hip and Knee Clinic at Sydney Olympic Park

Sydney, New South Wales, Australia

Mater Health Services

South Brisbane, Queensland, Australia

John Flynn Hospital

Tugun, Queensland, Australia

Epworth Centre

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

14-4542-03

Identifier Type: -

Identifier Source: org_study_id