The goal of this clinical investigation is to assess the early migration of the Symax stem and the precision of the RSA measurements done at this hospital. Also clinical outcome and patient satisfaction will be assessed.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study objective is to determine the prosthetic migration of the
Symax stem in the first two years after implantation
Secondary outcome
Secundary objectives are the clinical outcome of these patients and the patient
satisfaction. And also the assessment of the precision of RSA measurements in
this hospital.
Background summary
Cementless hip arthroplasty is one of the most successful orthopaedic
techniques. Still the survival of hip implants is not indefinite. One of the
causes for implant failure in loosening and osteolysis as a consequence of
particulate wear and stress shielding.
The Symax hip used in this study is designed to optimize stability, fixation
and preservation of bone stock, to prevent loosening. By way of measurements of
micromotion in the first years after implantation a long term prediction can be
made of prosthetic loosening. A very accurate way to measure micromotion is
roentgen stereophotogrammetric Aanalysis (RSA).
Study objective
The goal of this clinical investigation is to assess the early migration of the
Symax stem and the precision of the RSA measurements done at this hospital.
Also clinical outcome and patient satisfaction will be assessed.
Study design
This is a prospective clinical follow up study with a group of 26 patients who
will receive a RSA Symax hip stem. The selection of a control group was not
possible since there are no RSA hip stems of comparable hip prosthesis.
Intervention
The study population will get a cementless RSA Symax hip arthroplasty. To do
the symax measurements correctly a number of tantallum markers will be inserted
into the femur during surgery. This will lead to a minor lengthening of
operating time. A few days after surgery and during the follow up period
thereafter a number of RSA X-rays will be made.
Study burden and risks
During this study a number of RSA X-rays will be made. At some follow ups these
X-rays will replace the normally made X-rays to minimize the radiation load of
the patients. Patients will also be asked to fullfill two questionnaires at
regular intervals.
The measurements of early migration will benifit the patient and has to be
researched in this catagory of patients.
Koeweistraat 8
4181 CD Waardenburg
Nederland
Koeweistraat 8
4181 CD Waardenburg
Nederland
Listed location countries
Age
Inclusion criteria
age between 18 and 70 years
Patients requiring uncemented primary THA
Patients with a diagnosis of osteoarthritis, rheumatoid arthritis, avascular necrosis or post-traumatic arthritis
Exclusion criteria
patients who require a revision of previous implanted THA
Patients with BMI>35
Patients who have had a prior procedure of femoral osteotomy
patients with active or suspected infection
patients with malignancy
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 | NL16089.068.07 |