A prospective clinical follow up study with a New Press-fit Cup with initial RSA analysis (NPC).

Completed

• Conditions: Osteoarthritis; worn hip; 10023213

• Registration Number: NL-OMON46964
• Lead Sponsor: Stichting SCORE

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-01-02
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the migration of the cup measured with RSA. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Subjective outcome (PROMS), complications and survival. </p><br>