An observational study in Arthritis, Degenerative, Arthritis, Rheumatoid and Hip Fractures, sponsored by Aesculap AG. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by Aesculap AG (part of B. Braun) · Observational
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.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
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Patients with indication for cementless primary Total Hip Arthroplasty
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Exclusion Criteria:
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2017; primary completion for Dec 2017, 4 months later.
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This study is withdrawn, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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