BoneMaster ITo perform a comparative assessment between the clinical, bone remodelling, and radiographic outcomes (as measured with RSA) of the conventional Hydroxyl-Apetite (HA) Taperloc stem compared with Taperloc stem with additional BoneMaster®…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Micro-motion measured with RSA x-ray
Secondary outcome
- Radiographic assessment: filling, wear, varus/valgus etc.
- Quality of life (SF-12 questionnaire)
- Function score (HOOS en HHS)
Background summary
The incidence of revision surgery in THRs will increase extensively the
forthcoming decade due to increased life expectancy, the implantation of THR in
younger patients and the increasing prevalence of THRs.
Aseptic mechanical loosening starts with micromotion, in the range of 0.2 to
1.0 mm, of the prosthesis relative to the surrounding bone.
Stability of an implant is achieved during surgery (primary stability) and will
increase afterwards (secondary stability). Press-fit ensures primary stability
of cement-less components. Due to the favourable biomimetic properties,
nanotechnology BoneMaster® coating is expected to enhance faster ingrowth.
Study objective
BoneMaster I
To perform a comparative assessment between the clinical, bone remodelling, and
radiographic outcomes (as measured with RSA) of the conventional
Hydroxyl-Apetite (HA) Taperloc stem compared with Taperloc stem with additional
BoneMaster® coating in patients undergoing primary uncemented THA over a period
of 5 years. Bone remodelling and all complications will be documented.
BoneMaster II
To perform a comparative assessment between the clinical, bone remodelling, and
radiographic outcomes (as measured with RSA) of the conventional
Hydroxyl-Apetite (HA) Taperloc stem or cemented Taperloc stem compared with
Taperloc stem with additional BoneMaster® coating in patients undergoing
primary THA over a period of 5 years. Bone remodelling and all complications
will be documented.
Study design
Patients who are planned for a total hipprothesis and meeting the inclusion
criteria. After informed consent patients will be randomised prior to OK.
BoneMaster I
Randomisation Taperloc BoneMaster stem or Taperloc HA coated stem
BoneMaster II
Randomisation Taperloc BoneMaster stem or Taperloc HA coated stem or Taperloc
cemented stem
Patients will be seen pre, 3mnd, 6mnd, 1yr, 2yr en 5yr after OK on the
outpatient clinic. During these follow-up moments patients will have to fill in
some questionnaires (HOOS, SF-12 en HHS), routine questionnaires. And
furthermore extra RSA X-rays will be made.
Intervention
Taperloc BoneMaster stem
Study burden and risks
Extent of burden is taken into account, patients have to make more X-rays. A
RSA X-ray will take approximately 10 minutes, in total 7 extra X-rays will be
taken. So a maximum of 1,5 hour is asked from the patients, equally divided
over 5 years.
Bronovolaan 5 nvt
DEN HAAG 2597 AX
NL
Bronovolaan 5 nvt
DEN HAAG 2597 AX
NL
Listed location countries
Age
Inclusion criteria
BMI < 40
suitable for a Taperloc stem
diagnosis osteoarthritis or avascular necrosis
ASA classification I-III
Exclusion criteria
THR 6 months prior to surgery with unsatisfactory results
other major operation 12 weeks prior to THR
Dutch language not mastered
history of alcohol or drugs abuse
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL22820.098.08 |