The effect of Refobacin and Palacos bone cement on fixation of total hip prosthesis (THP): A clinical RSA-study on a force enclosed stem.

Phase 4

• Conditions: Prosthesis fixation / loosening; 10005944

• Registration Number: NL-OMON30670
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Pre-treatment evaluation will consist of clinical assessment, and medical<br /><br>history, functional evaluation (using different score forms) and by<br /><br>radiographic evaluation. After surgery evaluation will be performed on<br /><br>different intervals using measurements of RSA and functional evaluation (e.g.<br /><br>pain, work/activity level). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>None</p><br>