Total Hip Arthroplasty (THA)NCT03646513
A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
An observational study of Total Hip Arthroplasty (THA), run by Smith & Nephew, Inc. at 1 site in Australia.
Trial summary
This is a prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in approximately 26 subjects, at one site in Australia, who have been implanted with the SMF Short Modular Femoral Stem Hip System in a primary THA procedure to assess its safety and efficacy up to 20 years… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- SMF Short Modular Femoral Hip System
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Feb 2019to 12 Mar 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects that have been implanted with the SMF Short Modular Femoral Stem primary stem for primary total hip arthroplasty.
Who may be able to join
- The participant has undergone primary total hip arthroplasty with the SMF short modular femoral stem at the study site and still has the original implant at the time of Ethics Committee approval of the study.
- The participant is willing and able to participate in follow-up visits at the study site.
Who cannot join
- The Subject, in the opinion of the PI, has an emotional or neurological condition that would affect their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
- Subject is known to be at risk for lost to follow-up or failure to return for scheduled visits.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in approximately 26 subjects, at one site in Australia, who have been implanted with the SMF Short Modular Femoral Stem Hip System in a primary THA procedure to assess its safety and efficacy up to 20 years post-surgery.
Read the detailed description
This is a single arm, consecutive series study to collect relevant clinical, laboratory and radiological data in up to 26 subjects, who have been implanted with the SMF Short Modular Femoral Stem THA system at 1 site in Australia.
The Baseline visit will be determined as the first visit to site after Ethics approval. This will be approximately 8-9 years post implant. Enrolled subjects will be followed up to 20 years post SMF implant.
Eligible patients will be contacted and patient status and implant revision status will be assessed at this initial contact. The subject will be given the option to participate in a prospective 12 year on-site follow-up visits for which they will provide written informed consent. Subjects who are lost to follow-up, deceased or are unwilling/unable to participate in the prospective study will be noted in the subject files and this data will be captured for analysis of study results. Data will be collected on the operative date, and implant status.
Post Baseline, the study will allow for metal ion assessments every 3 years for asymptomatic subjects and annual assessments for subjects with pain, swelling, and/or functional limitations if assessed by the Principal Investigator to be related to the SMF implant, having ruled out all other probable causes for the subject. If the subject has elevated whole blood cobalt or chromium (defined as >7ppb) a MARS MRI or CT will be obtained. These types of imaging techniques are aimed at detecting inflammatory degenerative evolution of peri articular soft tissues including pseudo-tumours. A functional Questionnaire, HOOS JR Questionnaire will be completed at all patient site visits.
Safety will be evaluated by assessing the frequency and nature of adverse events, serious adverse events and revisions.
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- SMF Short Modular Femoral Hip System
- Keywords
- THA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMF Short Modular Femoral Hip SystemDevice
Primary Total Hip Arthroplasty with SMF Short Modular Femoral Stem Hip System.
| Study group | Role | What they receive |
|---|---|---|
| SMF Short Modular Femoral Stem Implanted Subjects | Subjects who have been implanted with the SMF Short Modular Femoral Stem for primary total hip arthroplasty. Receives: Device: SMF Short Modular Femoral Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metal Ion Level
All participants at Baseline and every three years afterwards up to 20 years will have whole blood collected for metal ion testing of whole blood cobalt (Co) and chromium (Cr). Symptomatic participants with pain, swelling, and/or functional limitations if assessed by the Principal Investigator to be related to the implant will have whole blood collected for metal ion testing of cobalt and chromium annually.
Measured: Baseline to Study Completion, up to 20 years
Number of Participants With Cobalt (Co) and Chromium (Cr) Metal Ions > 7 Parts-Per-Billion (Ppb)
Number of participants with whole blood cobalt (Co) and/or chromium (Cr) > 7 ppb (Yes/No). Participants as 'Yes' to Co and/or Cr will have Metal Artifact Reduction Sequence (MARS) Magnetic Resonance Imaging (MRI) performed (or Computerized tomography (CT) if MRI is contraindicated). This is used to detect pseudotumors, abductor muscle atrophy, and tendinous pathology in patients with painful metal-on-metal (MOM) hip arthroplasty.
Measured: Baseline to study completion, up to 20 years
Secondary outcomes (4)
Number of Participants With Short Modular Femoral (SMF) Stem Revision
Number of participants with a revision of any component of the SMF Short Modular Femoral Stem for any reason as a result of an adverse event. Revisions captured at any time during the study duration (up to 20 years) from the point of informed consent signing.
Measured: Study Completion, up to 20 years
Radiographic Assessment: Loosening
Standard of Care Radiographic Assessment for loosening indicated by radiolucencies > 2 millimeters (mm). In a cemented arthroplasty, this lucency at the bone-cement interface indicates the formation of a fibrous membrane (representing the lucency). Periprosthetic lucencies wider than 2 mm and/or progressive lucencies are signs of abnormality.
Measured: Baseline to study completion, up to 20 years
Radiographic Assessments: Surface Wear
Number of participants with evidence of surface wear (Yes/No) as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities such as pseudo tumors or corrosion.
Measured: Baseline to study completion, up to 20 years
The Hip Osteoarthritis Outcomes Score Junior (HOOS JR) Questionnaire
The HOOS JR. questionnaire consists of 6 questions. These focus on 3 categories: joint pain, stiffness and function in daily living. The HOOS JR. questionnaire, allows patients to rate each activity by indicating the amount of pain or disability they experience while carrying them out. Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability (i.e., worse outcome) and 100 is perfect joint health (i.e., best outcome).
Measured: Baseline to study completion, up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start14 Feb 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: Product recalled. Sponsor decision to discontinue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen McMahon, Principal investigator, Malabar Orthopaedic Institute, Melbourne, Australia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646513
- Sponsor's protocol ID
- 18- 4550- 01
- Status last verified
- Jan 2024
- First submitted
- 16 Jul 2018
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
- ClinicalTrials.gov ID
- NCT03646513
- Acronym / sponsor ID
- 18- 4550- 01
- Conditions
- Total Hip Arthroplasty (THA)
- Keywords
- THA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Product recalled. Sponsor decision to discontinue study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 19 Mar 2024
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 prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in approximately 26 subjects, at one site in Australia, who have been implanted with the SMF Short Modular Femoral Stem Hip System in a primary THA procedure to assess its safety and efficacy up to 20 years post-surgery.
Detailed description
This is a single arm, consecutive series study to collect relevant clinical, laboratory and radiological data in up to 26 subjects, who have been implanted with the SMF Short Modular Femoral Stem THA system at 1 site in Australia.
The Baseline visit will be determined as the first visit to site after Ethics approval. This will be approximately 8-9 years post implant. Enrolled subjects will be followed up to 20 years post SMF implant.
Eligible patients will be contacted and patient status and implant revision status will be assessed at this initial contact. The subject will be given the option to participate in a prospective 12 year on-site follow-up visits for which they will provide written informed consent. Subjects who are lost to follow-up, deceased or are unwilling/unable to participate in the prospective study will be noted in the subject files and this data will be captured for analysis of study results. Data will be collected on the operative date, and implant status.
Post Baseline, the study will allow for metal ion assessments every 3 years for asymptomatic subjects and annual assessments for subjects with pain, swelling, and/or functional limitations if assessed by the Principal Investigator to be related to the SMF implant, having ruled out all other probable causes for the subject. If the subject has elevated whole blood cobalt or chromium (defined as >7ppb) a MARS MRI or CT will be obtained. These types of imaging techniques are aimed at detecting inflammatory degenerative evolution of peri articular soft tissues including pseudo-tumours. A functional Questionnaire, HOOS JR Questionnaire will be completed at all patient site visits.
Safety will be evaluated by assessing the frequency and nature of adverse events, serious adverse events and revisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMF Short Modular Femoral Stem Implanted Subjects | – | Device: SMF Short Modular Femoral Hip SystemSubjects who have been implanted with the SMF Short Modular Femoral Stem for primary total hip arthroplasty. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that have been implanted with the SMF Short Modular Femoral Stem primary stem for primary total hip arthroplasty.
Key inclusion criteria (2 listed)
- The participant has undergone primary total hip arthroplasty with the SMF short modular femoral stem at the study site and still has the original implant at the time of Ethics Committee approval of the study.
- The participant is willing and able to participate in follow-up visits at the study site.
Key exclusion criteria (2 listed)
- The Subject, in the opinion of the PI, has an emotional or neurological condition that would affect their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
- Subject is known to be at risk for lost to follow-up or failure to return for scheduled visits.
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 |
|---|---|---|
| SMF Short Modular Femoral Hip SystemPrimary Total Hip Arthroplasty with SMF Short Modular Femoral Stem Hip System. | Device | SMF Short Modular Femoral Stem Implanted Subjects |
Primary outcome
Metal Ion Level
Time frame: Baseline to Study Completion, up to 20 years
All participants at Baseline and every three years afterwards up to 20 years will have whole blood collected for metal ion testing of whole blood cobalt (Co) and chromium (Cr). Symptomatic participants with pain, swelling, and/or functional limitations if assessed by the Principal Investigator to be related to the implant will have whole blood collected for metal ion testing of cobalt and chromium annually.
Number of Participants With Cobalt (Co) and Chromium (Cr) Metal Ions > 7 Parts-Per-Billion (Ppb)
Time frame: Baseline to study completion, up to 20 years
Number of participants with whole blood cobalt (Co) and/or chromium (Cr) > 7 ppb (Yes/No). Participants as 'Yes' to Co and/or Cr will have Metal Artifact Reduction Sequence (MARS) Magnetic Resonance Imaging (MRI) performed (or Computerized tomography (CT) if MRI is contraindicated). This is used to detect pseudotumors, abductor muscle atrophy, and tendinous pathology in patients with painful metal-on-metal (MOM) hip arthroplasty.
4 secondary outcomes
Number of Participants With Short Modular Femoral (SMF) Stem Revision
Time frame: Study Completion, up to 20 years
Radiographic Assessment: Loosening
Time frame: Baseline to study completion, up to 20 years
Radiographic Assessments: Surface Wear
Time frame: Baseline to study completion, up to 20 years
The Hip Osteoarthritis Outcomes Score Junior (HOOS JR) Questionnaire
Time frame: Baseline to study completion, up to 20 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stephen McMahon principal investigator
Malabar Orthopaedic Institute, Melbourne, Australia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty (THA), run by Smith & Nephew, Inc. at 1 site 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 2 inclusion and 2 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Metal Ion Level (time frame: Baseline to Study Completion, up to 20 years). The study lists 2 primary outcomes in all. 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 19 Mar 2024.