The goal of this clinical investigation is to assess the early migration and bone remodeling of the Symax hip stem and the Trident HA coated or Trident Tritanium acetabulum component with RSA and 18-F PET CT Also the sensitivity of the RSA…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to determine the prosthetic migration of the
uncemented Trident acetabular component (Tritanium or HA coated (controls))
and the uncemented HA coated Symax stem from post-op until 2 years after
implantation using the model based RSA technique.
Secondary outcome
The secondary objective of this study is to asses clinical outcome and patient
satisfaction in patients implanted with the uncemented Trident acetabular
component (Tritanium or HA coated (controls)) and the uncemented HA-coated
Symax hip stem from post-op until 2 years after implantation using the Harris
Hip Score, Oxford Hip Score, WOMAC and EQ-5D questionnaires at pre-op, 12w,
26w, 52w and 104w.
The tertiary objective of this study is to assess bone remodeling of the
uncemented Trident acetabular component (Tritanium or HA coated (controls)) and
the uncemented HA-coated Symax hip stem from post-op until 2 years after
implantation using QCT derived from using F18-Fluoride PET (Positron Emission
Tomography) in a cohort of 12 consecutive patients (to be exact patients 11-23
in inclusion scheme) at 12, 26, 52 and 104 weeks post-op.
The fourth objective of this study is to determine prosthetic migration and
patient satisfaction at 5 years after surgery.
A hip implant that is initially properly fixed to the bone, can show
micromovement after some years. This can be a first sign of loosening,
resulting in implant failure. So 5 year post-operative evaluation is important
to confirm quality and safety of this implant as well as to determine the
predictive capacity of RSA in terms of mid- and long term implant survival.
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). The development to optimalise prosthesis fixation is tsill
ongoing. At the moment, in Maastricht, the Trident HA coated acetabulum
component is the implant of choice. Th etrident Tritanium acetabulum component
does not have a HA coating but instead a porous metal structure that facilitaes
bone ingrowth and subsequently leading to component fixation. A second aim of
our study is the asssessment of both fixation methods and based on our
hypothesis that theTrident Tritanium acetabulum component will have a better
fixation compared with the Trident HA coated acetabulum component as measured
by RSA and 18F PET CT.
Study objective
The goal of this clinical investigation is to assess the early migration and
bone remodeling of the Symax hip stem and the Trident HA coated or Trident
Tritanium acetabulum component with RSA and 18-F PET CT Also the sensitivity of
the RSA measurements done at AZm will be assessed . Furthermore, complications,
clinical outcome and patient satisfaction will be assessed and clinical
function questionnaires filled in by doctors and patients will be evaluated.
Study design
This is a prospective clinical follow up study with an RCT design in a single
centre. A group of 50 patients who will receive a Symax hip stem. with also a
Trident HA coated acetabulum component or Trident Tritanium acetabulum
component.
Intervention
All study patinets willbe implanted with an uncemented Trident HA coated or
Trident Tritanium acetabulum component and an uncemented Symax HA coated hip
prothesis. To adequately measure RSA a number of tantalum beads (diameter
0.8mm) will be placed in the femoral and pelvic bone which leads to a minimal
extension of surgery time. A number of days after surgery and during subsequent
follow-up times RSA x-rays will be made for implant migration research. and
standard X-rays and 18F PET CT willbe made to evaluate bone remodleing and
implant fixation.
Study burden and risks
Tijdens deze studie worden standaard rontgenfoto's, RSA rontgenfoto's en 18-F
PET CT scans gemaakt. De stralenbelasting hiervan staat beschreven protocol
pagina 11. Verder worden de patienten gevraagd om op vaste tijdstippen een
aantal vragenlijstjes in te vullen. Risico's aan dit onderzoek zijn verder niet
anders dan de risico's van een totale heupoperatie
During this study standard X-rays, RSA X-rays eand 18-F PET CT scans are made.
The radiation exposure is described in the protocol page 11.
The patients are also asked to fill in some questionnaires at regular follow-up
visits in the clinic. Further there are no more risks dan the standard risks
associated with total hip replacement.
P.Debeyelaan 25
Maastricht 6229 HX
NL
P.Debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Patients aged between 35 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
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 | NL33832.068.10 |