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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02799654
Other study ID # AAG-O-H-1612
Secondary ID
Status Withdrawn
Phase N/A
First received June 6, 2016
Last updated September 4, 2017
Start date August 2017
Est. completion date December 2019

Study information

Verified date September 2017
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2019
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Germany Prof. Dr. med. E. Mayr Celle

Sponsors (1)

Lead Sponsor Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Osteolysis over time (localized bone resorption) radiological evaluation will be done according to the (A/P) Gruen zones 3, 12 and 24 months postoperative
Secondary 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
Secondary Cortical thinning radiological evaluation will be done according to the (A/P) Gruen zones 3, 12 and 24 months postoperative
Secondary Hypertrophy radiological evaluation will be done according to the (A/P) Gruen zones 3, 12 and 24 months postoperative
Secondary 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
Secondary Adverse Events / Serious Adverse Events Rates of Adverse Events / Serious Adverse Events are recorded until 24 months postoperative
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