To perform a comparative assessment between the clinical and radiographic outcomes (as measured with RSA) of the Maxera Ceramic cup versus the standard uncemented polyethylene Allofit Cup all combined with the ML Taper stem in patients undergoing…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome will be clinically measured using the Harris Hip Score (HHS), Oxford
Hip score (OHS) and EQ5-D, whilst radiographic outcomes will be evaluated
through standard radiographic parameters which include qualitative femoral and
acetabular findings as well as position of the stem and cup. RSA will be used
to measure prostheses migration.
Secondary outcome
not applicable
Background summary
The Maxera Cup provides a large-head, ceramic-on-ceramic option for the younger
and more active patient. The cup is an established hemispherical design. It is
a cup system that offers high range of motion and a low-wear bearing to better
enable the restoration of a patient*s active lifestyle. The wear rates for
Biolox delta material have been confirmed in vitro by hip simulator tests.
By mixing Zirconia and other oxide additives into the Alumina matrix, a
composite is created that results in a significant reduction of the ceramic
femoral head fracture rate. Nowadays the risk of poor performing survival over
time should be limited to the max. The only clinical test that can provide data
to predict long survival is stability testing with RSA. As a result, the risk
of implanting potentially inferior prostheses in patients will be reduced,
resulting in less suffering for patients and a reduction in healthcare
expenses.
It is hypothesized that the clinical results, radiographic outcomes, implant
survival, overall pain and functional performances of the Maxera Cup are equal
to the Allofit Cup, up to five years of follow-up.
Study objective
To perform a comparative assessment between the clinical and radiographic
outcomes (as measured with RSA) of the Maxera Ceramic cup versus the standard
uncemented polyethylene Allofit Cup all combined with the ML Taper stem in
patients undergoing primary uncemented THA over a period of 5 years (primary
objective is stability over 2 years). All complications will be documented.
Study design
A prospective randomised clinical trial in which 50 cases (25 vs. 25) will be
enrolled over one hospital. The primary components to be implanted are an
uncemented ML Taper stem combined with the uncemented Maxera or Allofit cup
cup. All patients will have a Ceramic head. Patients will be evaluated
preoperatively and postoperatively at discharge (from operation date to date of
discharge), at 6 weeks, 3 months, 6 months,1 year, 2 years and 5 years.
Intervention
Placement of an uncemented Maxera® or Allofit® cup in combination with an
uncemented ML Taper stem®.
Study burden and risks
Subjects participating in the study have the same risks and benefits when not
participating in the study. All components used in the study have CE mark and
are already in use. Besides standard radiological follow-up, RSA x-rays will be
made to measure the fixation of the prostheses.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
Inclusion criteria
1. Male and non-pregnant females : <= 75 years
2. Patients with a Quetelet index (QI=weight in (kilogram)/ square length
(meters)) < 35.
3. Patients requiring primary THR, suitable for the use of the Maxera Cup
and Allofit Cup.
4. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis.
5. The individual is physically and mentally willing and able to comply with
postoperative functional evaluation and able to participate in an appropriate
rehabilitation schedule.
6. ASA classification score I-III.
7. Patients who signed the Ethics Committee approved specific Informed Consent
Form prior to surgery.
Exclusion criteria
1. Patients who had a THA on contralateral side more than 6 months ago and the
rehabilitation period outcome is considered unsatisfactory or not good.
(Patients with contra-lateral THA >6 months ago with good outcome (Harris Hip
Score >85) can be included in the study).
2. Patients who had a THA on contralateral side less than 6 months ago.
3. Patients with a major surgical procedure during the 12 weeks before the
study-related operation.
4. Dutch language not mastered
5. The patient is unwilling to cooperate with the study
6. The patient is pregnant or desired to be pregnant after surgery or is using
inadequate birth control
7. Recent Myocardial infarct or CVA (<3 months).
8. Mentally disabled patients.
9. Patients with a Quetelet index (QI=weight in (kilogram)/ square length
(meters)) > 35.
10. Any active infection
11. Current malignancy
12. Uncontrolled hypertension
13. Known history of alcohol or drugs abuse.
14. ASA IV-V
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL47440.098.14 |
| OMON | NL-OMON26837 |