Primary objective is to assess the early stability of the Delta-TT cup and H-MAX femoral stem. Additionally, the stability of the Delta-TT cup with Polyethylene insert is compared to the Delta-TT cup with Ceramic insert by means of RSA. Secondary…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the early stability of the Delta-TT cup with
Polyethylene insert, the Delta-TT cup with Ceramic insert and the H-MAX femoral
stem after two years by means of RSA. The RSA data of the components will be
described in terms of subsidence, linear, and rotational movements.
Secondary outcome
Secondary objective is to study the stability of the C2 femoral stem and
compare the migration results with the migration results of the H-MAX femoral
stem as well as relevant migration results of similar stems from the literature.
The third objective is to predict the long-term survival of the different
implants based on the two and five-year migration patterns and correlate the
clinical factors, clinical scores and radiographic aspects with the RSA
results.
Background summary
The acetabulum cup is the weak link in a total hip arthroplasty, with a higher
revision number compared to the femoral stem. Rationale is that the insert
influences the modus of elasticity of the cup, which might influence the
osseointegration and thus the stability of the device. A titanium shell with a
ceramic inlay is stiffer than the same shell with a polyethylene liner.
However, the trabeculair titanium outer layer with its tremendous bone ingrowth
capacity can even well compensate for this potential negative aspect
Study objective
Primary objective is to assess the early stability of the Delta-TT cup and
H-MAX femoral stem. Additionally, the stability of the Delta-TT cup with
Polyethylene insert is compared to the Delta-TT cup with Ceramic insert by
means of RSA. Secondary objective is to study the stability of the C2 femoral
stem and compare the migration results with the migration results of the H-MAX
femoral stem as well as relevant migration results of similar stems from the
literature. The third objective is to predict the long-term survival of the
different implants based on the two and five-year migration patterns and
correlate the clinical factors, clinical scores and radiographic aspects with
the RSA results.
Study design
A Prospective Randomized Single Centre RSA Study
Intervention
Group A: 25 patients will receive the H-MAX femoral stem and the Delta-TT cup
with polyethylene insert.
Group B: 25 patients will receive the H-MAX femoral stem and the Delta-TT cup
with ceramic insert.
Group C: 15 patients will receive the C2 femoral stem and the Delta-TT cup with
ceramic insert (Cohort).
Study burden and risks
In addition to the benefits from the primary hip arthroplasty procedure e.g.
reduced pain, improved range of motion, there is no guarantee that patients
will personally benefit from inclusion in this study. Patients may undergo more
thorough screening and follow-up than non-study patients and may benefit from
this increased surveillance. The effective radiation dose per RSA-radiograph is
3 *Sv. The additional annual radiation dose is negligible if the natural annual
exposure of 2 mSv is considered and will do the patient no harm.
Via Nazionale 52
Villanova di San Daniele 33038
IT
Via Nazionale 52
Villanova di San Daniele 33038
IT
Listed location countries
Age
Inclusion criteria
A. Patients scheduled to undergo primary total hip replacement.
B. Patient is able to understand the meaning of the study and is willing to sign the METC approved, study-specific Informed Patient Consent Form.
C. Ability and willingness to follow instructions and to return for follow-up evaluations.
D. The subject is a male or non-pregnant female between 18 and 75 years of age.
Exclusion criteria
A. The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.
B. The subject will be operated bilaterally.
C. Patients having a deformity or disease located in other joints than the hip that needs surgery and is limiting their ability to walk.
D. The subject has an active or suspected latent infection in or about the hip joint.
E. Patient who is expected to need lower limb joint replacement for another joint within one year.
F. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
G. The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
H. The subject*s bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
I. Female patients planning a pregnancy during the course of the study.
J. The patient is unable or unwilling to sign the Informed Consent specific to this study.
K. Subject deemed unsuitable for participation in the study based on the investigator*s judgement.
Design
Recruitment
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 |
|---|---|
| ISRCTN | ISRCTNvolgt |
| CCMO | NL44230.100.13 |
| OMON | NL-OMON25653 |