Non-Interventional, Multicenter Bicontact® E PMCF Study

Completed

• Conditions: Femoral Neck Fractures; Femoral Head Necrosis; Degenerative Osteoarthritis; Rheumatoid Arthritis

• Registration Number: NCT03442855
• Lead Sponsor: Aesculap AG

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-22
• Primary Completion: 2018-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Indication for Bicontact E prosthesis THA
• Patients ≥ 18 years
• Patient not pregnant
• Written informed consent

Exclusion Criteria

• Patients receiving a bipolar implantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Results	1 year	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

Secondary Outcome Measures

Name	Time	Method
Thigh Pain	1 year	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 \[no pain - worst imaginable pain\].
X-Ray evaluation	1 year	Radiological results (osteointegration, migration)
(Serious) Adverse Events	1 year	Complications: Adverse Events (AE) / Serious Adverse Events (SAE)

Trial Locations

Locations (5)

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, Japan