DEXA Bone Density Analysis to Analyze the Loading Concept of the CoreHip® Prosthesis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Primary Osteoarthritis
- Sponsor
- Aesculap AG
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)
- Status
- Not Yet Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
Additional diagnostic examination: DEXA-Analysis. A DEXA scan is an imaging test that measures bone density (strength). The results can provide helpful details about risk for osteoporosis (bone loss) and fractures. Furthermore we would like to find out more about stress shielding processes around our prosthesis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Unilateral hip osteoarthritis
- •Indication for CoreHip Standard hip stem according to preoperative planning
- •Written Informed Consent
- •Age 35-85 years
- •According to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits
Exclusion Criteria
- •Femoral neck fractures
- •Pregnancy
- •BMI \> 35
- •History of femoral fracture or previous surgery on the same hip
- •Metabolic bone disease, use of steroids or other drugs affecting bone metabolism
- •Intraoperative bone cracks
- •Severe osteoarthritis of the contralateral hip
- •THA of the contralateral side or other event leading to restricted weight bearing during the study period
Outcomes
Primary Outcomes
Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)
Time Frame: within 24 months postoperative
Changes in bone mineral density (BMD) according to Gruen.
Secondary Outcomes
- Development of Forgotten Joint Score(preoperative, at discharge (1 week postop) and 12 months postoperative)
- Clinical Results: Joint Function (Harris Hip Score)(preoperative, at discharge (1 week postop) and 12 months postoperative)
- Development of Quality of Life (EQ-5D-5L)(preoperative, at discharge (1 week postop) and 12 months postoperative)
- Development of Pain(preoperative, at discharge (1 week postop) and 12 months postoperative)