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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03646513
Registration number
NCT03646513
Ethics application status
Date submitted
16/07/2018
Date registered
24/08/2018
Date last updated
19/03/2024
Titles & IDs
Public title
A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
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Scientific title
A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
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Secondary ID [1]
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18- 4550- 01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Total Hip Arthroplasty (THA)
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - SMF Short Modular Femoral Hip System
SMF Short Modular Femoral Stem Implanted Subjects - Subjects who have been implanted with the SMF Short Modular Femoral Stem for primary total hip arthroplasty.
Treatment: Devices: SMF Short Modular Femoral Hip System
Primary Total Hip Arthroplasty with SMF Short Modular Femoral Stem Hip System.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Metal Ion Level
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Study Completion, up to 20 years
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Primary outcome [2]
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Number of Participants With Cobalt (Co) and Chromium (Cr) Metal Ions > 7 Parts-Per-Billion (Ppb)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to study completion, up to 20 years
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Secondary outcome [1]
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Number of Participants With Short Modular Femoral (SMF) Stem Revision
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Assessment method [1]
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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.
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Timepoint [1]
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Study Completion, up to 20 years
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Secondary outcome [2]
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Radiographic Assessment: Loosening
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to study completion, up to 20 years
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Secondary outcome [3]
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Radiographic Assessments: Surface Wear
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to study completion, up to 20 years
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Secondary outcome [4]
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The Hip Osteoarthritis Outcomes Score Junior (HOOS JR) Questionnaire
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Assessment method [4]
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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).
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Timepoint [4]
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Baseline to study completion, up to 20 years
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Eligibility
Key inclusion criteria
- 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.
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Minimum age
55
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/03/2020
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Sample size
Target
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Accrual to date
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Final
4
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Malabar Orthopaedic Clinic - Windsor
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Recruitment postcode(s) [1]
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3181 - Windsor
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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 post-surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03646513
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen McMahon
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Address
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Malabar Orthopaedic Institute, Melbourne, Australia.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03646513
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