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 (part of B. Braun) · Observational
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Among 11 studies in Arthritis, Rheumatoid by B. Braun — 1 open to participants now, 3 under way, none of them phase 3. Arthritis, Rheumatoid · B. Braun.
Among the 11 studies in Arthritis, Rheumatoid by B. Braun, this one is one of 2 that started in 2017, is one of 7 observational ones, and was the 7th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →1 of the 11 studies in Arthritis, Rheumatoid by B. Braun is open now, in 2 countries. Recruiting first, the newest first:
Aesculap AG · Sites in Germany, United Kingdom
Ages 18+
By country, each count listing its studies:
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2017.
This study's enrollment of 73 is below the median of 176 across 1,017 observational studies indexed under Arthritis, Rheumatoid.
Median enrollment 95 across the 4 interventional studies, 84 across the 7 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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This study is registered under Aesculap AG, one of the names counted as B. Braun. Under that name alone:
Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
1 of the studies in Arthritis, Rheumatoid by B. Braun that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05302934Aesculap AGEvaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty | 2027-06 |
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Among the 11 studies in Arthritis, Rheumatoid by B. Braun, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
This study's enrollment of 73 is below the median of 176 across 1,017 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Compared within Arthritis, Rheumatoid, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Joint Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients receiving primary THA:
Acute disorders of the hip that cannot be treated by other therapies:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Ran from Feb 2017 to primary completion in May 2018, 15 months.
Of 155 industry-sponsored observational studies under Arthritis, Rheumatoid, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 116. This study's 15 months is below that.
Counting every sponsor, half of 391 studies reached it within 50 months; a quarter within 25 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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