The primary objective is to assess if there are any differences in terms of Bone Mineral Density between patients receiving the BICON-PLUS NT with an alumina reduced device surface (study group) and a group of patients receiving the BICON-PLUS with…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative bone minderal density (BMD)
Secondary outcome
- WOMAC (Western Ontario and McMaster Universities)
- Harris Hip Score
- Radiology: prevalence of radiolucent lines
Background summary
There is a need to develop a method that can reduce or eliminate the hard
particles contaminating grit-blasted surfaces without affecting too much the
overall topography.
Study objective
The primary objective is to assess if there are any differences in terms of
Bone Mineral Density between patients receiving the BICON-PLUS NT with an
alumina reduced device surface (study group) and a group of patients receiving
the BICON-PLUS with the conventional surface (control group).
The secondary objective is to assess if there are any clinical and radiographic
differences.
Study design
Randomized, double-blinded study
Intervention
- Total hip arthroplasty using a standard cup (Bicon-Plus)
- Total hip arthroplasty using a cup with a modified surface (Bicon-Plus NT)
Study burden and risks
- There will be 5 DEXA assessments (not performed in a normal clinical setting)
- The radiation dose from DEXA is very low (<<1 mSv). There is minimal risk
attributable to these assessments.
- There is no specific risk from the physical assessment and the patient
self-assessment.
Erlenstrasse 4a
6343 Rotkreuz
CH
Erlenstrasse 4a
6343 Rotkreuz
CH
Listed location countries
Age
Inclusion criteria
- Patients with primary or secondary osteoarthrosis
- Patients requiring primary arthroplasty
- Age at time of surgery: 50-70 years
Exclusion criteria
- Patients with rheumatoid arthritis
- Patients whose body mass index is higher than 35
- Patients requiring revision arthroplasty
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15752.094.07 |