Excia T Cementless EBRA Study

Withdrawn

• Conditions: Arthritis, Rheumatoid; Arthritis, Degenerative; Femur Head Necrosis; Hip Fractures

• Registration Number: NCT02799654
• Lead Sponsor: Aesculap AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Study Start: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-07
• Primary Completion: 2017-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
Cortical thinning	3, 12 and 24 months postoperative	radiological evaluation will be done according to the (A/P) Gruen zones
Hypertrophy	3, 12 and 24 months postoperative	radiological evaluation will be done according to the (A/P) Gruen zones
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
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

Trial Locations

Locations (1)

Prof. Dr. med. E. Mayr; 🇩🇪 Celle, Germany