Adults 55 to 90, any sex, with Total Hip Arthroplasty (THA). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Metal Ion LevelPrimary· Baseline to Study Completion, up to 20 years
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: Cobalt (Co)
Group
Value
95% CI
SMF Short Modular Femoral Stem Implanted Subjects
115.0
± 118.0
Baseline: Chromium (Cr)
Group
Value
95% CI
SMF Short Modular Femoral Stem Implanted Subjects
55.8
± 55.5
Number of Participants With Cobalt (Co) and Chromium (Cr) Metal Ions > 7 Parts-Per-Billion (Ppb)Primary· Baseline to study completion, up to 20 years
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: Cobalt (Co)
Group
Value
95% CI
SMF Short Modular Femoral Stem Implanted Subjects
2
SMF Short Modular Femoral Stem Implanted Subjects
2
Baseline: Chromium (Cr)
Group
Value
95% CI
SMF Short Modular Femoral Stem Implanted Subjects
0
SMF Short Modular Femoral Stem Implanted Subjects
4
20 Years: Cobalt (Co)
Group
Value
95% CI
20 Years: Chromium (Cr)
Group
Value
95% CI
The Hip Osteoarthritis Outcomes Score Junior (HOOS JR) QuestionnaireSecondary· Baseline to study completion, up to 20 years
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 (i.e., worse outcome) and 100 is perfect joint health (i.e., best outcome).
Baseline
Group
Value
95% CI
SMF Short Modular Femoral Stem Implanted Subjects
100
± 0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew, Inc.
Last refreshed: 19 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03646513.