In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and radiological results of the cementless Excia T® prosthesis in routine clinical use shall be assessed and the migration taking place in the first 24 months evaluated.
Study Type
OBSERVATIONAL
Prof. Dr. med. E. Mayr
Celle, Germany
Subsidence over time of Excia T® stem (EBRA-FCA)
The subsidence of the Excia T stem will be measured with Ein-Bild-Röntgen-Analysis Femoral Component Analysis (EBRA-FCA). EBRA allows a non-invasive measurement of routinely taken A/P radiographs. Necessary is a series of at least four x-rays that can be read by the EBRA software. The whole implant must be visible on the A/P x-ray, as well as the greater and lesser trochanter. Subsidence shall be measured on the follow-up x-rays in comparison to the discharge x-rays.
Time frame: discharge (approx. 1 week postop), 3, 12 and 24 months postoperative
Clinical Results over time (Harris Hip Score)
The clinical assessment will be done with the Harris Hip Score (HHS)
Time frame: preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative
Quality of Life over time (EQ-5D-5L)
The generic patient reported outcome score EQ-5D-5L will be used for the assessment of quality of life.
Time frame: preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative
Osteolysis over time (localized bone resorption)
radiological evaluation will be done according to the (A/P) Gruen zones
Time frame: 3, 12 and 24 months postoperative
Radiolucent lines over time
radiological evaluation will be done according to the (A/P) Gruen zones: ≤1mm, 1-2mm, ≥2mm
Time frame: 3, 12 and 24 months postoperative
Cortical thinning
radiological evaluation will be done according to the (A/P) Gruen zones
Time frame: 3, 12 and 24 months postoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hypertrophy
radiological evaluation will be done according to the (A/P) Gruen zones
Time frame: 3, 12 and 24 months postoperative
Mechanical Alignment over time
any change of the A/P implant angle (varus / valgus alignment) as assessed with EBRA-FCA will be evaluated
Time frame: discharge (approx. 1 week postop), 3, 12 and 24 months postoperative
Adverse Events / Serious Adverse Events
Rates of Adverse Events / Serious Adverse Events are recorded
Time frame: until 24 months postoperative