A post market clinical follow-up study with the Optimys Stem, with initial RSA analysis

A post market clinical follow-up study with the Optimys Stem, with initial RSA analysis - Optimys Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47653

Enrollment

150

Registered

2013-12-17

Start date

2014-02-24

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthroplasty Hip replacement

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Additionally survival, complications and quality of life will be documented.	—

Countries

Netherlands

Outcome results