Osteoarthritis, HipHISTORICNCT02435420
A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres (HISTORIC)
An observational study of Osteoarthritis, Hip and Arthritis, Degenerative, run by Smith & Nephew, Inc. at 8 sites in Australia.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hip, Arthritis, Degenerative
- What is being tested?
- EMPERION Modular Primary Stem
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 8 sitesAustralia
- Study dates
- 1 Aug 2015to 9 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects that have been implanted with the EMPERION modular primary stem for primary total hip arthroplasty.
Who may be able to join
- 1) Subject has undergone primary total hip arthroplasty with the EMPERION™ Modular hip system
Who cannot join
- Subject received the EMPERION™ THA on the affected hip as a revision for a previously failed THA
- At the time of surgery, subject had an active infection or sepsis (treated or untreated)
- At the time of surgery, subject had presence of malignant tumor, metastatic or neoplastic disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
Dubbo Base Hospital
Dubbo, New South Wales, 2830
Dubbo Private Hospital
Dubbo, New South Wales, 2830
Epworth Centre
Melbourne, Victoria, 3121
Mater Health Services
South Brisbane, Queensland, 4101
North Shore Private Hospital
Sydney, New South Wales, 2065
Royal North Shore Hospital
Sydney, New South Wales, 2065
Hip and Knee Clinic at Sydney Olympic Park
Sydney, New South Wales, 2127
John Flynn Hospital
Tugun, Queensland, 4224
About this study
Official title: 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.
Read the 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
- Being tested
- EMPERION Modular Primary Stem
- Keywords
- Total Hip Arthroplasty, EMPERION Modular Stem, Survivorship
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPERION Modular Primary StemDevice
Primary total hip arthroplasty using the EMPERION Modular Primary Stem
| Study group | Role | What they receive |
|---|---|---|
| EMPERION Modular Primary Stem subjects | All subjects have previously been implanted with the EMPERION Modular Primary Stem for primary total hip arthroplasty. Receives: Device: EMPERION Modular Primary Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of stem
Measured: 5 years
Secondary outcomes (4)
Revision for any reason
Measured: 5 years
Radiographic Assessment
Radiographic problems, component orientation, radiolucencies, migration, osteolysis, stress shielding, subsidence
Measured: 5 years
Harris Hip Score
Measured: 5 years
Adverse Events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start1 Aug 2015
- Primary completion9 Nov 2017
- Study completion9 Nov 2017
Why it stopped: Commercial decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr David Liu, BSc, M.B., B.S. F, Principal investigator, John Flynn Private Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435420
- Sponsor's protocol ID
- 14-4542-03
- Acronym
- HISTORIC
- Status last verified
- Feb 2018
- First submitted
- 30 Apr 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres
- ClinicalTrials.gov ID
- NCT02435420
- Acronym / sponsor ID
- HISTORIC / 14-4542-03
- Conditions
- Osteoarthritis, Hip, Arthritis, Degenerative
- Keywords
- Total Hip Arthroplasty, EMPERION Modular Stem, Survivorship
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Commercial decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMPERION Modular Primary Stem subjects | – | Device: EMPERION Modular Primary StemAll subjects have previously been implanted with the EMPERION Modular Primary Stem for primary total hip arthroplasty. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects that have been implanted with the EMPERION modular primary stem for primary total hip arthroplasty.
Key inclusion criteria (1 listed)
- 1) Subject has undergone primary total hip arthroplasty with the EMPERION™ Modular hip system
Key exclusion criteria (3 listed)
- Subject received the EMPERION™ THA on the affected hip as a revision for a previously failed THA
- At the time of surgery, subject had an active infection or sepsis (treated or untreated)
- At the time of surgery, subject had presence of malignant tumor, metastatic or neoplastic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPERION Modular Primary StemPrimary total hip arthroplasty using the EMPERION Modular Primary Stem | Device | EMPERION Modular Primary Stem subjects |
Primary outcome
Survivorship of stem
Time frame: 5 years
4 secondary outcomes
Revision for any reason
Time frame: 5 years
Radiographic Assessment
Time frame: 5 years
Harris Hip Score
Time frame: 5 years
Adverse Events
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Commercial decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr David Liu, BSc, M.B., B.S. F principal investigator
John Flynn Private Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Arthritis, Degenerative, run by Smith & Nephew, Inc. at 8 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Commercial decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship of stem (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.