Comparative roentgen stereophotogrammetry analysis of the Global Tissue Sparing (GTS) stem ® compared with uncemented HA coated Taperloc stem.
- Conditions
- joint wearosteoarthrosis10023213
- Registration Number
- NL-OMON55416
- Lead Sponsor
- Haaglanden Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
- Male and non-pregnant females : <= 70 years
- Patients with a Quetelet index (QI=weight in (kilogram)/ square length
(meters)) < 35.
- Patients requiring primary THR, suitable for the use of the GTS and Taperloc
stem.
- The patient is diagnosed with osteoarthritis (OA) or avascular necrosis.
- ASA classification score I-III.
- 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).
- Patients who had a THA on contralateral side less than 6 months ago.
- Patients with a major surgical procedure during the 12 weeks before the
study-related operation.
- Dutch language not mastered
- The patient is unwilling to cooperate with the study
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is stem migration at 2 years postoperatively measured with<br /><br>RSA analysis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Outcome will be clinically measured using the Harris Hip Score (HHS), HOOS<br /><br>(WOMAC) questionnaire, EQ5-D, whilst radiographic outcomes will be evaluated<br /><br>through standard radiographic parameters which include qualitative femoral and<br /><br>acetabular findings as well as position of the stem and cup. RSA will be used<br /><br>to measure stem migration.</p><br>