Observational clinical study of the CE-marked cemented A2(R) short stem - A2zem

ARTIQO GmbH0 sites140 target enrollmentApril 30, 2021

Overview

No summary available.

Registry

who.int

Start Date

April 30, 2021

End Date

TBD

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

ARTIQO GmbH

•1\. The subjects require a primary hip joint replacement and are candidates for an endoprosthetic fitting with the cemented A2® short stem in accordance with the purpose and indications and contraindications of the currently valid version of the instructions for use of the product.
•There is no restriction to certain indications within the intended use. Indications and contraindications according to the instructions for use of the cemented A2® hip stem are as follows:
•Indications
•\- Patients with advanced wear of the hip joint due to degenerative and post\-traumatic arthrosis or rheumatoid arthritis
•\- Avascular necrosis of the femoral head
•\- Acute traumatic fracture of the femoral head or neck, as long as stable anchorage of the implant is guaranteed.
•Contraindications
•\- Acute or chronic infections, local or systemic
•\- Severe muscular, nervous or vascular diseases that may endanger the affected extremities
•\- Fractures tangential to or extending beyond the base of the femoral neck which radiate into the trochanteric region or the calcar.

•a) Pre\-operative exclusion criteria
•1\. Previous bony or soft tissue surgery on the affected proximal femur (e.g., varicose osteotomy). Arthroscopic surgery is excluded.
•2\. Infection of the affected hip joint or systemic infection.
•4\. CCD angle above 145°.
•5\. CCD angle below 120°.
•6\. Proven allergy to components of the implanted prosthesis.
•7\. Known neurological disease with alteration of motor function, neurological function, as well as neurological or mental illnesses, which may affect an objective assessment of the patient's state of health or an evaluation of his hip joint.
•8\. Pregnant or lactating women and those who are planning to become pregnant in the next to 2 years (\+3 weeks) according to the index procedure.
•9\. BMI over 32
•10\. Known alcoholism or other relevant addictive diseases.