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

Smith & Nephew

Status: Terminated

Conditions: Osteoarthritis, Hip; Arthritis, Degenerative

Treatments: Device: EMPERION Modular Primary Stem

Study type: Observational

Funder types: Industry

Identifiers

NCT02435420

14-4542-03

Details and patient eligibility

About

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.

Full 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

Enrollment: 25 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

EMPERION Modular Primary Stem subjects

Description:

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

Treatment:

Device: EMPERION Modular Primary Stem