Excia T Cementless EBRA Study

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Non-Interventional Post Market Clinical Follow-up Study Excia T® Cementless EBRA Study

Conditions
-----------------
Arthritis, Degenerative, Arthritis, Rheumatoid, Hip Fractures, Femur Head Necrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written patient consent to study participation Age > 18 years Indication for primary THA with cementless Excia T® stem Exclusion Criteria: Pregnancy THA after fracture Rheumatoid arthritis Systemic disorders, treated with Cortisone or other pharmaceuticals, potentially compromising the bone quality Patient physically or mentally not able to follow the postoperative examination routine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | discharge (approx. 1 week postop), 3, 12 and 24 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Results over time (Harris Hip Score) | The clinical assessment will be done with the Harris Hip Score (HHS) | 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. | 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 | 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 | 3, 12 and 24 months postoperative | 
| Cortical thinning | radiological evaluation will be done according to the (A/P) Gruen zones | 3, 12 and 24 months postoperative | 
| Hypertrophy | radiological evaluation will be done according to the (A/P) Gruen zones | 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 | 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 | until 24 months postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Arthroplasty