Comparison of Zimmer Maxera Acetabular System to the Allofit Cup with Roentgen Stereophotogrammetric Analysis (RSA) in Total Hip Arthroplasty
Not Applicable
Completed
- Conditions
- <p>Hip osteoarthritis, Arthroplasty, Prosthesis, implant technical complications, Radio Stereometric Analysis</p>10023213
- Registration Number
- NL-OMON26837
- Lead Sponsor
- Department of orthopaedics, Reinier de Graaf Groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Male and non-pregnant females: = 75 years
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome is considered unstatisfactory or not good. (Patients with contralateral THA > 6 months ago with good outcome (Harris Hip Score > 85) can be included in the study).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cup migration, measured with RSA, is the primary outcome of this study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Outcome will be clinically measured using Harris Hip Score (HHS), Oxford Hip Score (OHS) and EQ-5D, whilst radiographic outcomes will be evaluated through standard radiographic parameters which include qualitative femoral and acetabular findings as well as position of the stem and cup.</p><br>