Clinical trial NCT03646513: A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
Official title: A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Total Hip Arthroplasty (THA)
Keywords: THA
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 4
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that have been implanted with the SMF Short Modular Femoral Stem primary stem for primary total hip arthroplasty.

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.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Metal Ion Level
timeFrame: Baseline to Study Completion, up to 20 years
measure: Number of Participants With Cobalt (Co) and Chromium (Cr) Metal Ions > 7 Parts-Per-Billion (Ppb)
timeFrame: Baseline to study completion, up to 20 years
Secondary outcomes:
measure: Number of Participants With Short Modular Femoral (SMF) Stem Revision
timeFrame: Study Completion, up to 20 years
measure: Radiographic Assessment: Loosening
timeFrame: Baseline to study completion, up to 20 years
measure: Radiographic Assessments: Surface Wear
timeFrame: Baseline to study completion, up to 20 years
measure: The Hip Osteoarthritis Outcomes Score Junior (HOOS JR) Questionnaire
timeFrame: Baseline to study completion, up to 20 years
Other outcomes:
Locations:
city: Windsor
country: Australia
facility: Malabar Orthopaedic Clinic
state: Victoria
Study officials:
affiliation: Malabar Orthopaedic Institute, Melbourne, Australia.
name: Stephen McMahon
role: PRINCIPAL_INVESTIGATOR
References: