This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.
The objectives of this study are to evaluate the safety and efficacy of the study device. This study will document any device-related, surgical or post-operative complication and adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems. Outcome measures will be quantified through statistical analysis of study device , HOOS questionnaire, radiographic assessments, Harris Hip Score, and adverse event reports.
Study Type
OBSERVATIONAL
Enrollment
126
Total hip arthroplasty
ZNA Middleheim
Berchem, Belgium
St. Michael's Hospital
Toronto, Ontario, Canada
Hopital Maisonneuve Rosemont, Hmr
Montreal, Quebec, Canada
CHUQ-L'Hôtel-Dieu de Québec
Québec, Quebec, Canada
Revision of the study device
Instances of required revision of the study device
Time frame: Discharge through 10 years
Device related Adverse Events
surgical, device-related, death and serious adverse events will be analyzed
Time frame: Implant through 10 years
Harris Hip Score
Questionnaire to calculate pain, walking abilities, activities, degrees of hip motion
Time frame: Baseline through 10 years
HOOS Questionnaire
Questionnaire to calculate hip symptoms, stiffness, pain, function and quality of life
Time frame: Baseline through 10 years
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St. Vincenz Hospital
Brakel, Germany
Brüderkrankenhaus St. Josef
Paderborn, Germany