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Change of organizational circumstances.
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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.
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indication for cementless primary Total Hip Arthroplasty
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. med. E. Mayr | Celle | 29223 | Germany |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D006620 | Hip Fractures |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |