Non-Interventional, Multicenter Bicontact® E PMCF Study

Rheumatoid Arthritis Clinical Trial

Official title:

Non-Interventional, Multicenter Bicontact® E PMCF Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442855
• Other study ID #: AAG-O-H-1417
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: September 2019
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for Bicontact E prosthesis THA

• Patients = 18 years

• Patient not pregnant

• Written informed consent

Exclusion Criteria:

• Patients receiving a bipolar implantation

Related Conditions & MeSH terms

• Degenerative Osteoarthritis
• Femoral Head Necrosis
• Femoral Neck Fractures
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Japan	Funabashi Orthopedic Hospital	Funabashi
Japan	Niigata Bandai Hospital	Niigata
Japan	Niigata Rinko Hospital	Niigata
Japan	Niigata Univ. Medical & Dental Hospital	Niigata
Japan	Saiseikai Niigata Second Hospital	Niigata

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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].	1 year
Secondary	X-Ray evaluation	Radiological results (osteointegration, migration)	1 year
Secondary	(Serious) Adverse Events	Complications: Adverse Events (AE) / Serious Adverse Events (SAE)	1 year