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CompletedNCT03442855Updated Sep 19, 2019

Non-Interventional, Multicenter Bicontact® E PMCF Study

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
73
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

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

Keywords

  • Arthroplasty, Replacement, Hip
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Patients receiving a bipolar implantation
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
73 participants (actual)
05

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. X-Ray evaluation

    Radiological results (osteointegration, migration)

    Time frame: 1 year

  3. (Serious) Adverse Events

    Complications: Adverse Events (AE) / Serious Adverse Events (SAE)

    Time frame: 1 year

06

Study locations

5 sites
  • 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
07

Registry details

Key details

Study ID
NCT03442855
Lead sponsor
Aesculap AG
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 1, 2017
Primary completion
May 31, 2018
Completion
May 31, 2019
Last update
Sep 19, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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