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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
Secondary ID [1] 0 0
18- 4550- 01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Arthroplasty (THA) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Metal Ion Level
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline to Study Completion, up to 20 years
Primary outcome [2] 0 0
Number of Participants With Cobalt (Co) and Chromium (Cr) Metal Ions > 7 Parts-Per-Billion (Ppb)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline to study completion, up to 20 years
Secondary outcome [1] 0 0
Number of Participants With Short Modular Femoral (SMF) Stem Revision
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Study Completion, up to 20 years
Secondary outcome [2] 0 0
Radiographic Assessment: Loosening
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline to study completion, up to 20 years
Secondary outcome [3] 0 0
Radiographic Assessments: Surface Wear
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Baseline to study completion, up to 20 years
Secondary outcome [4] 0 0
The Hip Osteoarthritis Outcomes Score Junior (HOOS JR) Questionnaire
Assessment method [4] 0 0
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).
Timepoint [4] 0 0
Baseline to study completion, up to 20 years

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.
Minimum age
55 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/03/2020
Sample size
Target
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Malabar Orthopaedic Clinic - Windsor
Recruitment postcode(s) [1] 0 0
3181 - Windsor

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Stephen McMahon
Address 0 0
Malabar Orthopaedic Institute, Melbourne, Australia.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03646513