To document the initial stabilty of the Optimys stem with radiostereometric analysis in the first 30 patients, and to perform a clinical follow up of at least 150 patient treated with this implant to document the outcome.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the first part of the study the initial migration measured by RSA will be
the primary outcome. For the whole PCMF the HOOS is the primary final outcome.
Secondary outcome
Additionally survival, complications and quality of life will be documented.
Background summary
One of the advantages of short-stemmed uncemented femoral components in total
hip arthroplasty could be that proximal femoral bone stock is preserved by load
transfer to the femoral metaphysis. Several other advantages for short stem
femoral implants are coined, the natural biomechanical situation could be more
easily restored and that a more tissue sparing approach can be used due to
easier insertion. The design of the short stem prosthesis is based on
established short stem philosophy with good clinical outcome. The implant shall
combine the benefits of short stems, for instance methaphyseal anchorage,
preserving of femoral bone stock, reduced stress shielding, etc., with
reliability and effectiveness of standard primary total hip arthroplasties.
Study objective
To document the initial stabilty of the Optimys stem with radiostereometric
analysis in the first 30 patients, and to perform a clinical follow up of at
least 150 patient treated with this implant to document the outcome.
Study design
Prospective single arm follow up study with initial RSA analysis.
Study burden and risks
Risk is comparable to the standard treatment of hip arthroplasty.
Burden is additional time at the follow up moments to fill in the
questionnaires and additional RSA X-rays at follow up for the first 30
patients.
Olympiadelaan 6
Amstelveen 1183WN
NL
Olympiadelaan 6
Amstelveen 1183WN
NL
Listed location countries
Age
Inclusion criteria
• Suffer from primary or secondary coxarthrosis.
• Be ready to participate in the follow-up examinations mentioned above
• Be between 18 and 85 years old at the time of inclusion
• Be a candidate for a primary implantation of a hip endoprosthesis
• Be expected to recover completely
• Have a BMI of 35 or less
Exclusion criteria
• Simultaneous participation in another clinical study or documentation with other orthopaedic implants of competitors.
• Suffer from the exclusion criteria: sepsis or malignant tumours.
• Have an ASA Classification > 3.
• Have a revision surgery
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 | NL47055.048.13 |