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

NCT03646513 | Terminated Results

• 1 other identifier: 18- 4550- 01
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty (THA)

Keywords

THA

Outcome Measures

Primary Outcomes (2)

• Metal Ion Level

  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.

  Baseline to Study Completion, up to 20 years

• Number of Participants With Cobalt (Co) and Chromium (Cr) Metal Ions > 7 Parts-Per-Billion (Ppb)

  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.

  Baseline to study completion, up to 20 years

Secondary Outcomes (4)

• Number of Participants With Short Modular Femoral (SMF) Stem Revision

  Study Completion, up to 20 years

• Radiographic Assessment: Loosening

  Baseline to study completion, up to 20 years

• Radiographic Assessments: Surface Wear

  Baseline to study completion, up to 20 years

• The Hip Osteoarthritis Outcomes Score Junior (HOOS JR) Questionnaire

  Baseline to study completion, up to 20 years

Study Arms (1)

SMF Short Modular Femoral Stem Implanted Subjects

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

Device: SMF Short Modular Femoral Hip System

Interventions

SMF Short Modular Femoral Hip System DEVICE

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

SMF Short Modular Femoral Stem Implanted Subjects

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

Malabar Orthopaedic Clinic

Windsor, Victoria, 3181, Australia

Location

Limitations and Caveats

The study was prematurely termination by the Sponsor with a limited number of enrolled participants. Only preoperative (baseline) participant data was available because no participant completed any follow-up visits due to early termination of the study.

Results Point of Contact

• Title: Andrew Copey
• Organization: Smith+Nephew, Inc.

andrew.copley@smith-nephew.com

+61.490.503.157

Study Officials

• Stephen McMahon

  Malabar Orthopaedic Institute, Melbourne, Australia.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 24, 2018
• Study Start: February 14, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-01

Locations

AU (1)