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Non-Interventional, Multicenter Bicontact® E PMCF Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03442855
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : March 19, 2019
Information provided by (Responsible Party):
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

Condition or disease
Degenerative Osteoarthritis Rheumatoid Arthritis Femoral Neck Fractures Femoral Head Necrosis

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional, Multicenter Bicontact® E PMCF Study
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Clinical Results [ Time Frame: 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 :
  1. Thigh Pain [ Time Frame: 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].

  2. X-Ray evaluation [ Time Frame: 1 year ]
    Radiological results (osteointegration, migration)

  3. (Serious) Adverse Events [ Time Frame: 1 year ]
    Complications: Adverse Events (AE) / Serious Adverse Events (SAE)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving primary THA:

Acute disorders of the hip that cannot be treated by other therapies:

  • Degenerative osteoarthritis
  • Rheumatic arthritis
  • Joint fractures
  • Femoral head necrosis

Inclusion Criteria:

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

Exclusion Criteria:

- Patients receiving a bipolar implantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03442855

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Contact: Anne-Katrin Wacker +49-7461-95-1509
Contact: Kazuyuki Kuroda 0081338142539

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Funabashi Orthopedic Hospital Active, not recruiting
Funabashi, Japan
Niigata Bandai Hospital Active, not recruiting
Niigata, Japan
Niigata Rinko Hospital Active, not recruiting
Niigata, Japan
Niigata Univ. Medical & Dental Hospital Recruiting
Niigata, Japan
Contact: Dai Miyasaka, MD         
Saiseikai Niigata Second Hospital Active, not recruiting
Niigata, Japan
Sponsors and Collaborators
Aesculap AG

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Responsible Party: Aesculap AG Identifier: NCT03442855     History of Changes
Other Study ID Numbers: AAG-O-H-1417
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aesculap AG:
Arthroplasty, Replacement, Hip

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Femoral Neck Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries