Degenerative Osteoarthritis, Femoral Head Necrosis, Femoral Neck Fractures, Rheumatoid Arthritis
Conditions
Keywords
Arthroplasty, Replacement, Hip
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
Interventions
None listed
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for Bicontact E prosthesis THA * Patients ≥ 18 years * Patient not pregnant * Written informed consent
Exclusion criteria
\- Patients receiving a bipolar implantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Results | 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
| Measure | Time frame | Description |
|---|---|---|
| Thigh Pain | 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 \[no pain - worst imaginable pain\]. |
| X-Ray evaluation | 1 year | Radiological results (osteointegration, migration) |
| (Serious) Adverse Events | 1 year | Complications: Adverse Events (AE) / Serious Adverse Events (SAE) |
Countries
Japan
Outcome results
None listed