Degenerative OsteoarthritisNCT03442855
Non-Interventional, Multicenter Bicontact® E PMCF Study
An observational study of Degenerative Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG at 5 sites in Japan.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Femoral Neck Fractures
- How many people
- 73 participants
- Where
- 5 sitesJapan
- Study dates
- 1 Feb 2017to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Indication for Bicontact E prosthesis THA
- Patients ≥ 18 years
- Patient not pregnant
- Written informed consent
Who cannot join
- Patients receiving a bipolar implantation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Funabashi Orthopedic Hospital
Funabashi
Niigata Bandai Hospital
Niigata
Niigata Rinko Hospital
Niigata
Niigata Univ. Medical & Dental Hospital
Niigata
Saiseikai Niigata Second Hospital
Niigata
About this study
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
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Femoral Neck Fractures, Femoral Head Necrosis
- Keywords
- Arthroplasty, Replacement, Hip
- Medical subject headings
- Joint Diseases, Arthritis, Rheumatoid, Femoral Neck Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
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].
Measured: 1 year
X-Ray evaluation
Radiological results (osteointegration, migration)
Measured: 1 year
(Serious) Adverse Events
Complications: Adverse Events (AE) / Serious Adverse Events (SAE)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Feb 2017
- Primary completion31 May 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442855
- Sponsor's protocol ID
- AAG-O-H-1417
- Status last verified
- Sep 2019
- First submitted
- 6 Feb 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional, Multicenter Bicontact® E PMCF Study
- ClinicalTrials.gov ID
- NCT03442855
- Acronym / sponsor ID
- AAG-O-H-1417
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Femoral Neck Fractures, Femoral Head Necrosis
- Keywords
- Arthroplasty, Replacement, Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Indication for Bicontact E prosthesis THA
- Patients ≥ 18 years
- Patient not pregnant
- Written informed consent
Key exclusion criteria (1 listed)
- Patients receiving a bipolar implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Thigh Pain
Time frame: 1 year
X-Ray evaluation
Time frame: 1 year
(Serious) Adverse Events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Results (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019; AzTrials last refreshed its copy on 29 Oct 2026.