A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System

NCT ID: NCT03646513

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-14
• Study Completion Date: 2020-03-12

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.

Conditions

Total Hip Arthroplasty (THA)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SMF Short Modular Femoral Stem Implanted Subjects

Subjects who have been implanted with the SMF Short Modular Femoral Stem for primary total hip arthroplasty.

SMF Short Modular Femoral Hip System

Intervention Type: DEVICE

Primary Total Hip Arthroplasty with SMF Short Modular Femoral Stem Hip System.

Interventions

SMF Short Modular Femoral Hip System

Primary Total Hip Arthroplasty with SMF Short Modular Femoral Stem Hip System.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen McMahon

Role: PRINCIPAL_INVESTIGATOR

Malabar Orthopaedic Institute, Melbourne, Australia.

Locations

Malabar Orthopaedic Clinic

Windsor, Victoria, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18- 4550- 01

Identifier Type: -

Identifier Source: org_study_id