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

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Hip; Arthritis, Degenerative
• Intervention / Treatment: Device: EMPERION Modular Primary Stem

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

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Dubbo, New South Wales, Australia, 2830
      • Dubbo Base Hospital
    • Dubbo, New South Wales, Australia, 2830
      • Dubbo Private Hospital
    • Sydney, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • Sydney, New South Wales, Australia, 2065
      • North Shore Private Hospital
    • Sydney, New South Wales, Australia, 2127
      • Hip and Knee Clinic at Sydney Olympic Park
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Health Services
    • Tugun, Queensland, Australia, 4224
      • John Flynn Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3121
      • Epworth Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects that have been implanted with the EMPERION modular primary stem for primary total hip arthroplasty.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EMPERION Modular Primary Stem subjects; All subjects have previously been implanted with the EMPERION Modular Primary Stem for primary total hip arthroplasty.	Device: EMPERION Modular Primary Stem; Primary total hip arthroplasty using the EMPERION Modular Primary Stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survivorship of stem	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score		5 years
Revision for any reason		5 years
Radiographic Assessment	Radiographic problems, component orientation, radiolucencies, migration, osteolysis, stress shielding, subsidence	5 years
Adverse Events		5 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Dr David Liu, BSc, M.B., B.S. F, John Flynn Private Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): November 9, 2017
• Study Completion (Actual): November 9, 2017

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Survivorship; EMPERION Modular Stem
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 14-4542-03