The objective of this study is to assess the difference in micromotion of the Stanmore hip prosthesis (form enclosed), using two different bone cements. We hypothesise that the newly marketed bone cement Refobacin- gentamycine has the same in vivo…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pre-treatment evaluation will consist of clinical assessment, and medical
history, functional evaluation (using different score forms) and by
radiographic evaluation. After surgery evaluation will be performed on
different intervals using measurements of RSA and functional evaluation (e.g.
pain, work/activity level).
Secondary outcome
None
Background summary
Palacos that is marketed since 1985, has been found with very good clinical
results concerning survival rate of cemented prostheses. Refobacin contains the
same ingredients as Palacos, however in different proportions and has gained
CE-approval. However clinical studies evaluating the two bone cements are
lacking.
Study objective
The objective of this study is to assess the difference in micromotion of the
Stanmore hip prosthesis (form enclosed), using two different bone cements. We
hypothesise that the newly marketed bone cement Refobacin- gentamycine has the
same in vivo properties as the Palacos bone cement. These properties are
evaluated by micromotion patterns of the hip stem and cup of the prosthesis as
measured by RSA (radiostereometry).
Study design
A prospective randomised blinded study will be performed. The study will be
conducted in one hospital in The Netherlands and patients will be followed
until death or when the prosthesis is removed. Patients will be randomized in
one of the two bone cement groups (either Palacos or Refobacin, both with
gentamycine, and will be followed on different intervals. For follow-up
Roentgen Stereophotogrammetric Analysis is used in combination with regular
clinical evaluation.
Study burden and risks
Patients are not at risk to receive high doses of radiation and there is no
enlarged risk for infections, migration, bone loss and pain associated. Future
benefits for the patients are that this study will give more insight in the
understanding of the fixating of prostheses, resulting in better designs and
techniques of total hip prosthesis (Stanmore hip).
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Patients with primary and secondary osteoarthritis who need a total hip prosthesis;
Patients capable of giving informed consent and expressing a willingness to comply with the post-operative review program
Exclusion criteria
Patients requiring revision arthroplasty;
Patients with primairy bone disease
The patient is unable or unwilling to sign the Patient Informed Consent (PIC) specific to this study
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 | NL16073.058.07 |