About this trial
The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary cementless stem. The DEXA bone density analysis is used.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Unilateral hip osteoarthritis
Indication for CoreHip Standard hip stem according to preoperative planning
Written Informed Consent
Age 35-85 years
Disqualifiers
Femoral neck fractures
Pregnancy
BMI > 35
History of femoral fracture or previous surgery on the same hip
Trial design
Single group
Treatments tested in this trial
Primary hip replacement with cementless stem
DeviceTotal Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide.
Treatment groups
Trial outcomes
Primary outcomes
Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)
Changes in bone mineral density (BMD) according to Gruen.
Secondary outcomes
Clinical Results: Joint Function (Harris Hip Score)
The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time.
Development of Quality of Life (EQ-5D-5L)
The EQ-5D-5L score is a generic score used to document the well-being of the patient.
Development of Forgotten Joint Score
The EQ-5D-5L score is a generic score used to document the well-being of the patient.
Development of Pain
The development of pain is measured with the Visual analog scale \[VAS\] a measure of pain intensity. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[on 100-mm scale\].
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: