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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03646513




Registration number
NCT03646513
Ethics application status
Date submitted
16/07/2018
Date registered
24/08/2018
Date last updated
21/09/2018

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 Analysis as a safety assessment - All subjects at Baseline and every three years afterwards will have whole blood collected for metal ion testing of whole blood cobalt and chromium. Symptomatic subjects with pain, swelling, and/or functional limitations if assessed by the PI to be related to the implant will have whole blood collected for metal ion testing of cobalt and chromium annually.
Timepoint [1] 0 0
From date of first study visit at Baseline until a 12 year period of safety assessments.
Primary outcome [2] 0 0
MARS MRI/CT - Subjects with whole blood cobalt and/or chromium > 7 ppb will have MARS MRI (or CT if MRI is contraindicated) performed. 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
From date of first study visit at Baseline until a 12 year period of safety assessments.
Secondary outcome [1] 0 0
SMF Short Modular Femoral Stem Revision - Revision of any component of the SMF Short Modular Femoral Stem for any reason as a result of an adverse event.
Timepoint [1] 0 0
To be captured at any time during the study duration of 12 years from the point of informed consent signing.
Secondary outcome [2] 0 0
Standard of Care Radiographic assessments - Loosening as indicated by radiolucencies > 2mm. 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
From date of first study visit at Baseline until a 12 year period of safety assessments.
Secondary outcome [3] 0 0
Radiographic assessments - Evidence of surface wear as indicated by early osteolysis
Timepoint [3] 0 0
From date of first study visit at Baseline until a 12 year period of safety assessments.
Secondary outcome [4] 0 0
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 and 100 is perfect joint health.
Timepoint [4] 0 0
From date of first study visit at Baseline until a 12 year period of safety assessments.
Secondary outcome [5] 0 0
Adverse Events Assessment - Safety will be evaluated by assessing the frequency and nature of adverse events and serious adverse events to ascertain patient safety and relationship to the implant
Timepoint [5] 0 0
From date of first study visit at Baseline until a 12 year period of safety assessments.

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Kamla Raniga
Address 0 0
Country 0 0
Phone 0 0
+61409194229
Fax 0 0
Email 0 0
kamla.raniga@smith-nephew.com
Contact person for scientific queries

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