Excia T Cementless EBRA Study

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02799654
• Other study ID #: AAG-O-H-1612
• Status: Withdrawn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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Degenerative
• Arthritis, Rheumatoid
• Femur Head Necrosis
• Hip Fractures
• Necrosis
• Osteoarthritis

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