Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435420
Recruitment Status : Terminated (Commercial decision)
First Posted : May 6, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

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.

Condition or disease Intervention/treatment
Osteoarthritis, Hip Arthritis, Degenerative 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

Layout table for study information
Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : November 9, 2017
Actual Study Completion Date : November 9, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Survivorship of stem [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Revision for any reason [ Time Frame: 5 years ]
  2. Radiographic Assessment [ Time Frame: 5 years ]
    Radiographic problems, component orientation, radiolucencies, migration, osteolysis, stress shielding, subsidence

  3. Harris Hip Score [ Time Frame: 5 years ]
  4. Adverse Events [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects that have been implanted with the EMPERION modular primary stem for primary total hip arthroplasty.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435420


Locations
Layout table for location information
Australia, New South Wales
Dubbo Base Hospital
Dubbo, New South Wales, Australia, 2830
Dubbo Private Hospital
Dubbo, New South Wales, Australia, 2830
North Shore Private Hospital
Sydney, New South Wales, Australia, 2065
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Hip and Knee Clinic at Sydney Olympic Park
Sydney, New South Wales, Australia, 2127
Australia, Queensland
Mater Health Services
South Brisbane, Queensland, Australia, 4101
John Flynn Hospital
Tugun, Queensland, Australia, 4224
Australia, Victoria
Epworth Centre
Melbourne, Victoria, Australia, 3121
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Dr David Liu, BSc, M.B., B.S. F John Flynn Private Hospital
Layout table for additonal information
Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT02435420    
Other Study ID Numbers: 14-4542-03
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Keywords provided by Smith & Nephew, Inc.:
Total Hip Arthroplasty
EMPERION Modular Stem
Survivorship
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases