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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
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)
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
Timepoint [1] 0 0
Study Completion, up to 20 years
Secondary outcome [2] 0 0
Radiographic Assessment: Loosening
Timepoint [2] 0 0
Baseline to study completion, up to 20 years
Secondary outcome [3] 0 0
Radiographic Assessments: Surface Wear
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
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.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03646513
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03646513