An observational study in Degenerative Osteoarthritis, Rheumatoid Arthritis and Femoral Neck Fractures, sponsored by Aesculap AG. Completed at 5 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Aesculap AG · Observational
Prospective observational (non-interventional) cohort study, multi-centric in 5 study Centers in Japan to collect short term clinical and radiological results of the cementless Bicontact® E stem in a standard patient population used in routine clinical practice
Patients receiving primary THA:
Acute disorders of the hip that cannot be treated by other therapies:
Exclusion Criteria:
Clinical Results
Hip Score of the Japanese Orthopaedic Association (JOA): three categories-movement, mental, and pain-each comprising 7 items, for a total of 21 items to be used as evaluation criteria for hip-joint function
Time frame: 1 year
Thigh Pain
Pain as measured with the Visual Analog Scale (VAS): Visual analog scale \[VAS\] is a measure of pain intensity. It is a continuous scale comprised of a horizontal analog scale of 100 mm length. It is anchored by two verbal descriptors, one for each symptom extreme \[no pain - worst imaginable pain\].
Time frame: 1 year
X-Ray evaluation
Radiological results (osteointegration, migration)
Time frame: 1 year
(Serious) Adverse Events
Complications: Adverse Events (AE) / Serious Adverse Events (SAE)
Time frame: 1 year
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Aesculap AG