Comparative roentgen stereophotogrammetry analysis of the Global Tissue Sparing (GTS) stem® compared with uncemented HA coated Taperloc stem.
Completed
- Conditions
- Joint Arthroplasty, Taperloc, hip, RSA
- Registration Number
- NL-OMON22203
- Lead Sponsor
- MC HaaglandenReinier de Graaf Groep, Delft
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Male and non-pregnant females : ≤ 70 years;
2. Patients with a Quetelet index (QI=weight in (kilogram)/ square length (meters)) < 35;
Exclusion Criteria
1. Patients who had a THA on contralateral side more than 6 months ago and the
rehabilitation period outcome is considered unsatisfactory or not good. (Patients with
contra-lateral 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 Stem migration measured with RSA analysis.
- Secondary Outcome Measures
Name Time Method Clinical outcome:<br /><br>1. Harris Hip Score (HHS);<br /><br>2. HOOS questionnaire;<br /><br>3. EQ5-D;<br /><br>4. Standard radiographic parameters which include qualitative femoral and acetabular findings.