This study investigates if there are differences in function and wear between total hip arthroplasty with standard or large diameter femoral heads.
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Clinical outcome with focus on function using standard questionnaires and a
motion analysis measuring simple movements of daily living (e.g. gait).
Wear as femoral head penetration measured on conventional radiographs taken as
part of the clinical procedure anyway.
Secondary outcome
n.a.
Background summary
In total hip arthroplasty (THR) a metal femoral head runs in a polyethylene
(PE) insert. Crosslinked PE has been proven to significantly reduce wear
in-vivo. New generations of highly crosslinked PE (e.g. Stryker X3) have shown
to reduce wear by >95% in simulator studies even independent femoral head
diameter. Clinical studies have shown no measurable wear at 2 years.
Femoral heads with diameters larger than the standard size (28mm) restore more
closely the natural anatomy and thus promise to reduce the luxation risk and in
theory to improve post-op function or accelerate recovery.
Study objective
This study investigates if there are differences in function and wear between
total hip arthroplasty with standard or large diameter femoral heads.
Study design
Multi-center prospective randomised comparison between patients receiving
primary uncemented total hip arthroplasty either with a standard diameter or a
large diameter metal femoral head. Randomization is performed using a
designated computer software to assign patients to the study group (large
heads) and control group (small, standard heads).
Intervention
n.a.
Study burden and risks
There is no known risk associated with study participation due to intervention
as patients receive primary THR at state-of-the-art quality anyway.
There is no known risk associated with study participation due to measurements
as the motion analysis only measures movements of daily living which are
assessed by the doctor and physiotherapists as part of clinical follow-up
anyway (e.g. gait). Wear measurement is performed on radiographs taken as part
of clinical routine anyway.
Large diameter femoral heads promise benefits which require the clinical
investigation as in this study.
6401 CX Heerlen
NL
6401 CX Heerlen
NL
Listed location countries
Age
Inclusion criteria
Patients indicated for uncemented primary total hip arthroplasty
Exclusion criteria
Patients who had a total hip arthroplasty on the contra-lateral side within the last year.
Design
Recruitment
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 | NL22378.096.08 |