Arthritis, Degenerative, Arthritis, Rheumatoid, Femur Head Necrosis, Hip Fractures
Conditions
Keywords
Total Hip Arthroplasty
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.
Interventions
None listed
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subsidence over time of Excia T® stem (EBRA-FCA) | discharge (approx. 1 week postop), 3, 12 and 24 months postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life over time (EQ-5D-5L) | preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative | The generic patient reported outcome score EQ-5D-5L will be used for the assessment of quality of life. |
| Osteolysis over time (localized bone resorption) | 3, 12 and 24 months postoperative | radiological evaluation will be done according to the (A/P) Gruen zones |
| Radiolucent lines over time | 3, 12 and 24 months postoperative | radiological evaluation will be done according to the (A/P) Gruen zones: ≤1mm, 1-2mm, ≥2mm |
| Clinical Results over time (Harris Hip Score) | preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative | The clinical assessment will be done with the Harris Hip Score (HHS) |
| Hypertrophy | 3, 12 and 24 months postoperative | radiological evaluation will be done according to the (A/P) Gruen zones |
| Mechanical Alignment over time | discharge (approx. 1 week postop), 3, 12 and 24 months postoperative | any change of the A/P implant angle (varus / valgus alignment) as assessed with EBRA-FCA will be evaluated |
| Adverse Events / Serious Adverse Events | until 24 months postoperative | Rates of Adverse Events / Serious Adverse Events are recorded |
| Cortical thinning | 3, 12 and 24 months postoperative | radiological evaluation will be done according to the (A/P) Gruen zones |
Countries
Germany
Outcome results
None listed