Non-Interventional, Multicenter Bicontact® E PMCF Study

Aesculap AG73 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Osteoarthritis Rheumatoid Arthritis Femoral Neck Fractures Femoral Head Necrosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Indication for Bicontact E prosthesis THA * Patients ≥ 18 years * Patient not pregnant * Written informed consent Exclusion Criteria: \- Patients receiving a bipolar implantation

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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